The following data is part of a premarket notification filed by American Dade with the FDA for Ci-trol Heparin Controls, Low/high.
| Device ID | K812424 |
| 510k Number | K812424 |
| Device Name: | CI-TROL HEPARIN CONTROLS, LOW/HIGH |
| Classification | Assay, Heparin |
| Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-24 |
| Decision Date | 1981-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768003905 | K812424 | 000 |
| 00842768003899 | K812424 | 000 |
| 00842768019531 | K812424 | 000 |
| 00842768019548 | K812424 | 000 |