The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Protein C Reagent.
| Device ID | K002541 |
| 510k Number | K002541 |
| Device Name: | PROTEIN C REAGENT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-16 |
| Decision Date | 2000-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768008641 | K002541 | 000 |
| 00630414640655 | K002541 | 000 |