The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Ferritin Calibrator.
| Device ID | K983548 |
| 510k Number | K983548 |
| Device Name: | FERRITIN CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DADE BEHRING, INC. RT. 896, GLASCOW BLDG. 500 Newark, DE 19714 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft DADE BEHRING, INC. RT. 896, GLASCOW BLDG. 500 Newark, DE 19714 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-09 |
| Decision Date | 1998-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768013744 | K983548 | 000 |