The following data is part of a premarket notification filed by Chromogenix Ab with the FDA for Coamate Protein C Chromogenic Assay.
| Device ID | K922201 |
| 510k Number | K922201 |
| Device Name: | COAMATE PROTEIN C CHROMOGENIC ASSAY |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | CHROMOGENIX AB TALJEGARDSGATAN 3 Molndal, SE S-431 53 |
| Contact | Leif Aurell |
| Correspondent | Leif Aurell CHROMOGENIX AB TALJEGARDSGATAN 3 Molndal, SE S-431 53 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-11 |
| Decision Date | 1992-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950088875 | K922201 | 000 |