K884178 is an FDA 510(k) clearance for the DRUG CONTROL SET. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on February 17, 1989, 136 days after receiving the submission on October 4, 1988.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K884178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1988 |
| Decision Date | February 17, 1989 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |