510(k) K923623

Device
Il Test Alt, Pn 35311
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K923623
Product code
CKA
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-17
Date received
1992-07-21
Regulation
862.1030
Classification name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
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
MURACA, J
Address
113 Hartwell Ave. P.O. Box 9113 Lexington MA US 02173 02173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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