JHGClass II
Chromatographic Separation, Lecithin/sphingomyelin Ratio
Clinical Chemistry · 21 CFR 862.1455
MDR events2All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances7All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Malfunction1
Other1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
7 clearances for this product code
- Irvine Scientific Sales Co., Inc.Oct 18, 2006
K061549 · AMNIOSTAT-FLM-PG
- Abbott LaboratoriesJul 20, 1987
K871593 · TDXR FETAL LUNG MATURITY
- Hana Biologics, Inc.May 25, 1984
K834616 · AMNIO STAT-FLM AGGLUTINATION TEST
- Hana Biologics, Inc.Oct 21, 1982
K822150 · AMNISTAT-FLM
- Beckman Instruments, Inc.Dec 17, 1981
K813216 · SECURE FDI TEST KIT
- Helena LaboratoriesJun 25, 1981
K811588 · HELENA FETAL-TEK 200 METHOD
- Helena LaboratoriesJun 5, 1979
K790798 · FETAL MATURITY TEST PROCEDURE