CIJClass II
Saccharogenic, Amylase
Clinical Chemistry · 21 CFR 862.1070
MDR events1All time
Recalls1All time
Registered firms8Currently listed
510(k) clearances31All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
8 firms currently registered for this product code
510(k) clearances
31 clearances for this product code
- Pointe Scientific, Inc.,Dec 23, 2002
K023396 · AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
- Bayer Corp.Jul 22, 1999
K991817 · ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- Ac Biochemicals, Inc.Feb 4, 1998
K980013 · AMYLASE
- Randox Laboratories, Ltd.Jun 21, 1996
K953211 · AMYLASE (ETHYLIDENE PNGPG7) KIT
- Emd Chemicals, Inc.Dec 11, 1995
K951494 · AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
- Pointe Scientific, Inc.,Aug 1, 1994
K940735 · LIQUID AMYLASE (CNPG3) REAGENT SET
- Data Medical Associates, Inc.Mar 11, 1994
K940010 · DMA AMYLASE (DEMAND) PROCEDURE
- Olympus Corp.Oct 18, 1993
K931301 · OLYMPUS AMYLASE REAGENT