REFRACTOMETRIC, TOTAL PROTEIN

Single (specified) Analyte Controls (assayed And Unassayed)

PYRAMID BIOLOGICAL CORP.

The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for Refractometric, Total Protein.

Pre-market Notification Details

Device IDK933218
510k NumberK933218
Device Name:REFRACTOMETRIC, TOTAL PROTEIN
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant PYRAMID BIOLOGICAL CORP. 6473 VAN NUYS Van Nuys,  CA  91401
ContactJeanette R Porretta
CorrespondentJeanette R Porretta
PYRAMID BIOLOGICAL CORP. 6473 VAN NUYS Van Nuys,  CA  91401
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-01
Decision Date1994-02-17

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