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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nadh oxidation/nad reduction, alt/sgpt
510(k) Number K761269
Device Name GEMENI GPT (ALT) ASSAY
Applicant
ELECTRO-NUCLEONICS LABORATORIES, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
ELECTRO-NUCLEONICS LABORATORIES, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number862.1030
Classification Product Code
CKA  
Date Received12/16/1976
Decision Date 12/29/1976
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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