MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII

Test, Qualitative And Quantitative Factor Deficiency

MELOY LABORATORIES, INC.

The following data is part of a premarket notification filed by Meloy Laboratories, Inc. with the FDA for Meloy Immunostat Monoclonal Factor Viii.

Pre-market Notification Details

Device IDK841708
510k NumberK841708
Device Name:MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant MELOY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-23
Decision Date1984-07-19

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