K883190 is an FDA 510(k) clearance for the DADE TDM CONTROL. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on September 9, 1988, 43 days after receiving the submission on July 28, 1988.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K883190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1988 |
| Decision Date | September 09, 1988 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |