Submission Details
| 510(k) Number | K032057 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 02, 2003 |
| Decision Date | August 21, 2003 |
| Days to Decision | 50 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
Cleared
Special
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
Aug 2003
Decision
50d
Days
Class 2
Risk
About This 510(k) Submission
K032057 is an FDA 510(k) clearance for the TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on August 21, 2003, 50 days after receiving the submission on July 2, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.
Device Classification
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3250 |
Manufacturer
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