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510(k) K844168

Device
AMYLASE REAGENT CS-726
Applicant
FISHER SCIENTIFIC CO., LLC.
510(k) number
K844168
Product code
CJA  
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-20
Date received
1984-10-25
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
JACK C MCLAUGHLIN
Address
1 Reagent Ln. Fair Lawn NJ US 07410 07410

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
K884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.1988-12-09
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
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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