Enzymatic Methods, Galactose
Clinical Chemistry · 21 CFR 862.1310
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
6 recall events for this product code
- PerkinElmer LAS IncTerminatedSep 30, 2004
Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the specified range.
Z-1499-04 · View FDA record ↗ - Perkin Elmer Life and Analytical Sciences IncTerminatedJul 20, 2004
Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000
The device is not stable throughout its labeled expiration date.
Z-0514-04 · View FDA record ↗ - Perkin Elmer Life and Analytical Sciences IncTerminatedJul 20, 2004
Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000
The device is not stable throughout its labeled expiration date.
Z-0515-04 · View FDA record ↗ - PerkinElmer Life Sciences IncTerminatedJul 2, 2003
Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays.
The device is not stable throughout its labeled expiration date.
Z-0969-03 · View FDA record ↗ - PerkinElmer Life Sciences IncTerminatedJul 2, 2003
Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.
The device is not stable throughout its labeled expiration date.
Z-0970-03 · View FDA record ↗ - PerkinElmer Life Sciences IncTerminatedJul 2, 2003
Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays.
The device is not stable throughout its labeled expiration date.
Z-0971-03 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- Perkinelmer, Inc.Nov 6, 2019
K190335 · GSP Neonatal Total Galactose kit
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.Apr 28, 2014
K133652 · GSP NEONATAL TOTAL GALACTOSE KIT
- Astoria-Pacific, Inc.Jun 20, 2013
K121101 · SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
- Wallac OYAug 7, 2008
K071649 · NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
- Quantase , Ltd.Jun 21, 1999
K990644 · QUANTASE TOTAL GALACTOSE SCREENING ASSAY
- Quantase , Ltd.Jun 21, 1999
K990654 · QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
- Neometrics, Inc.Jun 16, 1999
K991498 · ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
- Isolab, Inc.Feb 1, 1996
K950481 · NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT