The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Monoclonal Free Protein S Antigen Test Kit.
Device ID | K983914 |
510k Number | K983914 |
Device Name: | REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | CORGENIX, INC. 12061 TEJON ST. Westminster, CO 80234 |
Contact | Nanci Dexter |
Correspondent | Nanci Dexter CORGENIX, INC. 12061 TEJON ST. Westminster, CO 80234 |
Product Code | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-04 |
Decision Date | 1998-12-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00855360006014 | K983914 | 000 |