The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Special Protein Calibrator.
| Device ID | K994291 |
| 510k Number | K994291 |
| Device Name: | DIMENSION SPECIAL PROTEIN CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 ROUTE 896, GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Richard M Vaught |
| Correspondent | Richard M Vaught DADE BEHRING, INC. P.O. BOX 6101 ROUTE 896, GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-21 |
| Decision Date | 2000-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005190 | K994291 | 000 |