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 |