REAADS PROTEIN C ANTIGEN TEST KIT

Test, Qualitative And Quantitative Factor Deficiency

REAADS MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Reaads Medical Products, Inc. with the FDA for Reaads Protein C Antigen Test Kit.

Pre-market Notification Details

Device IDK972342
510k NumberK972342
Device Name:REAADS PROTEIN C ANTIGEN TEST KIT
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant REAADS MEDICAL PRODUCTS, INC. 12001 TEJON ST. SUITE 120 Westminister,  CO  80234
ContactNanci Dexter
CorrespondentNanci Dexter
REAADS MEDICAL PRODUCTS, INC. 12001 TEJON ST. SUITE 120 Westminister,  CO  80234
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-24
Decision Date1997-10-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855360006021 K972342 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.