K933557 is an FDA 510(k) clearance for the REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE. This device is classified as a Drug Specific Control Materials (Class I - General Controls, product code LAS).
Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on September 10, 1993, 51 days after receiving the submission on July 21, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K933557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1993 |
| Decision Date | September 10, 1993 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LAS — Drug Specific Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |