KHMClass II
Nephelometric, Amylase
Clinical Chemistry · 21 CFR 862.1070
MDR events0All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances6All time
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
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Hi Chem, Inc.Jun 30, 1983
K831295 · AMYLASE REAGENT #88129
- Pointe Scientific, Inc.,Oct 6, 1981
K812699 · AMYLASE
- BioscientificSep 9, 1981
K812447 · AMYLASE REAGENT KIT
- Stat EngineeringJun 9, 1980
K801096 · PERKIN ELMER MODEL 91 AMYLASE REAGENT
- Alta Diagnostics, Inc.Jul 17, 1979
K790797 · AMYLASE REAGENT SET
- Bd Becton Dickinson Vacutainer Systems PreanalyticApr 26, 1977
K770400 · REAGENT, AMYLASE LIPASE