CJAClass II
Amyloclastic, Amylase
Clinical Chemistry · 21 CFR 862.1070
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances10All 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
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
10 clearances for this product code
- Hichem DiagnosticsDec 22, 1989
K895555 · MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
- A-Kem, Inc.Dec 9, 1988
K884226 · AMYLASE REAGENT KIT FOR ASTRA SYSTEMS
- Wako Chemicals USA, Inc.Aug 30, 1988
K883059 · WAKO(TM) AUTOKIT AMYLASE
- Baxter Healthcare CorpNov 23, 1987
K873520 · PARAMAX AMYLASE REAGENT
- J. D. Assoc.Sep 9, 1986
K863052 · ALPHA AMYLASE
- Electro-Nucleonics Laboratories, Inc.Sep 9, 1986
K862640 · AMYLASE LTS
- Sterling Diagnostics, Inc.Feb 28, 1986
K860530 · AMYLASE REAGENT SET (MODIFIED CARAWAY)
- Fisher Scientific Co., LLCNov 20, 1984
K844168 · AMYLASE REAGENT CS-726