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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 K780636
Device Name SINGLE VIAL 10 SGPT-TRIS
Applicant
Boehringer Mannheim Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Boehringer Mannheim Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1030
Classification Product Code
CKA  
Date Received04/17/1978
Decision Date 05/18/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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