The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Apolipoprotein Standard Serum.
| Device ID | K041870 |
| 510k Number | K041870 |
| Device Name: | N APOLIPOPROTEIN STANDARD SERUM |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | DADE BEHRING, INC. 514 GBC DR. Newark, DE 19702 |
| Contact | Donna A Wolf |
| Correspondent | Donna A Wolf DADE BEHRING, INC. 514 GBC DR. Newark, DE 19702 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-09 |
| Decision Date | 2004-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768011535 | K041870 | 000 |