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510(k) K884226

Device
AMYLASE REAGENT KIT FOR ASTRA SYSTEMS
Applicant
A-KEM, INC.
510(k) number
K884226
Product code
CJA  
Decision
Substantially Equivalent (SESE)
Decision date
1988-12-09
Date received
1988-10-06
Regulation
862.1070
Classification name
Amyloclastic, Amylase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
STEVEN LEE
Address
P.O. Box 1589 82 Industrial E. Clifton NJ US 07015 07015

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CJA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K895555MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)Hichem Diagnostics1989-12-22
K883059WAKO(TM) AUTOKIT AMYLASEWako Chemicals USA, Inc.1988-08-30
K873520PARAMAX AMYLASE REAGENTBaxter Healthcare Corp1987-11-23
K862640AMYLASE LTSElectro-Nucleonics Laboratories, Inc.1986-09-09
K863052ALPHA AMYLASEJ. D. Assoc.1986-09-09
K860530AMYLASE REAGENT SET (MODIFIED CARAWAY)Sterling Diagnostics, Inc.1986-02-28
K844168AMYLASE REAGENT CS-726Fisher Scientific Co., LLC1984-11-20
K843529ASTRA SYSTEMS AMYLASE REAGENT KITBeckman Instruments, Inc.1984-10-11
K833864AMYLASE REAGENT SET-MODIFIED CARAWAYSterling Biochemical, Inc.1984-01-13

Legacy Summary#

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FDA Review#

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