The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Rapitex (r) Crp New.
| Device ID | K903853 |
| 510k Number | K903853 |
| Device Name: | RAPITEX (R) CRP NEW |
| Classification | System, Test, C-reactive Protein |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-21 |
| Decision Date | 1990-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768012778 | K903853 | 000 |
| 00842768011085 | K903853 | 000 |
| 00842768011078 | K903853 | 000 |