CJA · Class II · 21 CFR 862.1070

FDA Product Code CJA: Amyloclastic, Amylase

Leading manufacturers include Beckman Instruments, Inc., Fisher Scientific Co., LLC and Sterling Diagnostics, Inc..

10
Total
10
Cleared
53d
Avg days
1984
Since

FDA 510(k) Cleared Amyloclastic, Amylase Devices (Product Code CJA)

10 devices
1–10 of 10
Cleared Dec 22, 1989
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
K895555
Hichem Diagnostics
Chemistry · 107d
Cleared Aug 30, 1988
WAKO(TM) AUTOKIT AMYLASE
K883059
Wako Chemicals USA, Inc.
Chemistry · 42d
Cleared Nov 23, 1987
PARAMAX AMYLASE REAGENT
K873520
Baxter Healthcare Corp
Chemistry · 83d
Cleared Sep 09, 1986
AMYLASE LTS
K862640
Electro-Nucleonics Laboratories, Inc.
Chemistry · 61d
Cleared Sep 09, 1986
ALPHA AMYLASE
K863052
J. D. Assoc.
Chemistry · 28d
Cleared Feb 28, 1986
AMYLASE REAGENT SET (MODIFIED CARAWAY)
K860530
Sterling Diagnostics, Inc.
Chemistry · 16d
Cleared Nov 20, 1984
AMYLASE REAGENT CS-726
K844168
Fisher Scientific Co., LLC
Chemistry · 26d
Cleared Oct 11, 1984
ASTRA SYSTEMS AMYLASE REAGENT KIT
K843529
Beckman Instruments, Inc.
Chemistry · 34d

About Product Code CJA - Regulatory Context