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510(k) K895850

Device
SYNCHRON CX SYSTEMS (LAP) REAGENT KIT
Applicant
BECKMAN INSTRUMENTS, INC.
510(k) number
K895850
Product code
JGG  
Decision
Substantially Equivalent (SESE)
Decision date
1989-12-05
Date received
1989-10-03
Regulation
862.1460
Classification name
L-leucine-4-nitroanilide (colorimetric), Leucine Arylamidase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM T RYAN
Address
200 S. Kraemer Blvd., W-337 Box 8000 Brea CA US 92622 92622

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JGG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K844965LEUCINE AMINOPEPTIDASE REAGENTAlladin Diagnostic, Inc.1985-03-05

Legacy Summary#

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FDA Review#

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