QUANTA LITE RIBOSOME P ELISA

Anti-ribosomal P Antibodies

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Ribosome P Elisa.

Pre-market Notification Details

Device IDK981237
510k NumberK981237
Device Name:QUANTA LITE RIBOSOME P ELISA
ClassificationAnti-ribosomal P Antibodies
Applicant INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego,  CA  92131
ContactBrys C Myers
CorrespondentBrys C Myers
INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego,  CA  92131
Product CodeMQA  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-03
Decision Date1998-06-05

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