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510(k) K992140

Device
PICCOLO METLYTE 7 REAGENT DISC
Applicant
ABAXIS, INC.
510(k) number
K992140
Product code
JLB  
Decision
Substantially Equivalent (SESE)
Decision date
1999-08-26
Date received
1999-06-24
Regulation
862.1210
Classification name
Atp And Creatine Kinase (enzymatic), Creatine
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LISA MCGRATH
Address
1320 Chesapeake Ter. Sunnyvale CA US 94089 94089

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JLB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971817OLYMPUS CK-MB REAGENTOlympus America, Inc.1997-06-11
K782156UNITEST CREATINE KINASEBoehringer Mannheim Corp.1979-03-02

Legacy Summary#

summary

FDA Review#

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