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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Serological, Negative Control
510(k) Number K962399
Device Name HEPATITIS NEGATIVE CONTROL
Applicant
Pyramid Biological Corp.
6454 Van Nuys Blvd., Suite 111
Van Nuys,  CA  91401
Applicant Contact JEANETTE R PORRETTA
Correspondent
Pyramid Biological Corp.
6454 Van Nuys Blvd., Suite 111
Van Nuys,  CA  91401
Correspondent Contact JEANETTE R PORRETTA
Regulation Number862.1660
Classification Product Code
MJY  
Date Received06/21/1996
Decision Date 08/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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