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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K933218
Device Name REFRACTOMETRIC, TOTAL PROTEIN
Applicant
Pyramid Biological Corp.
6473 Van Nuys
Van Nuys,  CA  91401
Applicant Contact JEANETTE R PORRETTA
Correspondent
Pyramid Biological Corp.
6473 Van Nuys
Van Nuys,  CA  91401
Correspondent Contact JEANETTE R PORRETTA
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/01/1993
Decision Date 02/17/1994
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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