The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N High Sensitivity Crp.
| Device ID | K033908 |
| 510k Number | K033908 |
| Device Name: | N HIGH SENSITIVITY CRP |
| Classification | Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Kathleen A Dray-lyons |
| Correspondent | Kathleen A Dray-lyons DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | NQD |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-17 |
| Decision Date | 2004-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007736 | K033908 | 000 |
| 00842768007729 | K033908 | 000 |