N-ASSAY TIA MULTI V-NL

Method, Nephelometric, Immunoglobulins (g, A, M)

CRESTAT DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Crestat Diagnostics, Inc. with the FDA for N-assay Tia Multi V-nl.

Pre-market Notification Details

Device IDK933973
510k NumberK933973
Device Name:N-ASSAY TIA MULTI V-NL
ClassificationMethod, Nephelometric, Immunoglobulins (g, A, M)
Applicant CRESTAT DIAGNOSTICS, INC. 822 HAMPSHIRE RD. UNIT C Thousand Oaks,  CA  91361
ContactMary Rees
CorrespondentMary Rees
CRESTAT DIAGNOSTICS, INC. 822 HAMPSHIRE RD. UNIT C Thousand Oaks,  CA  91361
Product CodeCFN  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-13
Decision Date1994-01-28

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