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510(k) K971817

Device
OLYMPUS CK-MB REAGENT
Applicant
OLYMPUS AMERICA, INC.
510(k) number
K971817
Product code
JLB  
Decision
Substantially Equivalent (SESE)
Decision date
1997-06-11
Date received
1997-05-16
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
LAURA STORMS-TYLER
Address
Two Corporate Center Dr. Melville NY US 11747 11747

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JLB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992140PICCOLO METLYTE 7 REAGENT DISCAbaxis, Inc.1999-08-26
K782156UNITEST CREATINE KINASEBoehringer Mannheim Corp.1979-03-02

Legacy Summary#

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FDA Review#

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