The following data is part of a premarket notification filed by R2 Diagnostics, Inc. with the FDA for Fibrotek Fib.
| Device ID | K042919 |
| 510k Number | K042919 |
| Device Name: | FIBROTEK FIB |
| Classification | Test, Fibrinogen |
| Applicant | R2 DIAGNOSTICS, INC. 412 SOUTH LAFAYETTE BLVD. South Bend, IN 46601 |
| Contact | Peggy S Carter |
| Correspondent | Peggy S Carter R2 DIAGNOSTICS, INC. 412 SOUTH LAFAYETTE BLVD. South Bend, IN 46601 |
| Product Code | GIS |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-22 |
| Decision Date | 2004-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859394006040 | K042919 | 000 |