K935805 is an FDA 510(k) clearance for the PASCO MIC AND MIC/ID PANELS. This device is classified as a Susceptibility Test Powders, Antimicrobial (Class II - Special Controls, product code JTT).
Submitted by Pasco Laboratories, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on June 13, 1994, 193 days after receiving the submission on December 2, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K935805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1993 |
| Decision Date | June 13, 1994 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JTT — Susceptibility Test Powders, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |