The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Fibrinogen Calibrator Kit.
| Device ID | K072304 |
| 510k Number | K072304 |
| Device Name: | FIBRINOGEN CALIBRATOR KIT |
| Classification | Fibrinogen Standard |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101; MS 514 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo DADE BEHRING, INC. P.O. BOX 6101; MS 514 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Product Code | GFX |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-17 |
| Decision Date | 2007-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768008276 | K072304 | 000 |
| 00630414640631 | K072304 | 000 |