The following data is part of a premarket notification filed by Reaads Medical Products, Inc. with the FDA for Reaads Von Willebrand Factor Antigen Test Kit.
| Device ID | K972005 |
| 510k Number | K972005 |
| Device Name: | REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | REAADS MEDICAL PRODUCTS, INC. 12061 TEJON ST. Westminister, CO 80234 |
| Contact | Nanci Dexter |
| Correspondent | Nanci Dexter REAADS MEDICAL PRODUCTS, INC. 12061 TEJON ST. Westminister, 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 | 1997-05-30 |
| Decision Date | 1997-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855360006038 | K972005 | 000 |