ClearanceBrief
Panels › Clinical Chemistry › Product code CJA · Class 2

Amyloclastic, Amylase

Regulation 862.1070

0510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in CJA

Decided510(k)Device and applicantCode
Dec 22, 1989K895555MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
Hichem Diagnostics
CJA
Dec 9, 1988K884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMS
A-Kem, Inc.
CJA
Aug 30, 1988K883059WAKO(TM) AUTOKIT AMYLASE
Wako Chemicals USA, Inc.
CJA
Nov 23, 1987K873520PARAMAX AMYLASE REAGENT
Baxter Healthcare Corp
CJA
Sep 9, 1986K863052ALPHA AMYLASE
J. D. Assoc.
CJA
Sep 9, 1986K862640AMYLASE LTS
Electro-Nucleonics Laboratories, Inc.
CJA
Feb 28, 1986K860530AMYLASE REAGENT SET (MODIFIED CARAWAY)
Sterling Diagnostics, Inc.
CJA
Nov 20, 1984K844168AMYLASE REAGENT CS-726
Fisher Scientific Co., LLC
CJA
Oct 11, 1984K843529ASTRA SYSTEMS AMYLASE REAGENT KIT
Beckman Instruments, Inc.
CJA
Jan 13, 1984K833864AMYLASE REAGENT SET-MODIFIED CARAWAY
Sterling Biochemical, Inc.
CJA

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