K802038 is an FDA 510(k) clearance for the PHENYTOIN REAGENT TEST KIT. This device is classified as a Bacillus Subtilis Microbiology Assay, Tobramycin (Class II - Special Controls, product code DID).
Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980, 59 days after receiving the submission on August 25, 1980.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K802038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1980 |
| Decision Date | October 23, 1980 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DID — Bacillus Subtilis Microbiology Assay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |