FDA 510(k) Applications for Medical Device Product Code "CJA"
(Amyloclastic, Amylase)

FDA 510(k) Number Applicant Device Name Decision Date
K884226 A-KEM, INC. AMYLASE REAGENT KIT FOR ASTRA SYSTEMS 12/09/1988
K873520 BAXTER HEALTHCARE CORP. PARAMAX AMYLASE REAGENT 11/23/1987
K843529 BECKMAN INSTRUMENTS, INC. ASTRA SYSTEMS AMYLASE REAGENT KIT 10/11/1984
K862640 ELECTRO-NUCLEONICS LABORATORIES, INC. AMYLASE LTS 09/09/1986
K844168 FISHER SCIENTIFIC CO., LLC. AMYLASE REAGENT CS-726 11/20/1984
K895555 HICHEM DIAGNOSTICS MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) 12/22/1989
K863052 J. D. ASSOC. ALPHA AMYLASE 09/09/1986
K833864 STERLING BIOCHEMICAL, INC. AMYLASE REAGENT SET-MODIFIED CARAWAY 01/13/1984
K860530 STERLING DIAGNOSTICS, INC. AMYLASE REAGENT SET (MODIFIED CARAWAY) 02/28/1986
K883059 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT AMYLASE 08/30/1988


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