K934330 is an FDA 510(k) clearance for the TRANSGROW. This device is classified as a Culture Media, For Isolation Of Pathogenic Neisseria (Class II - Special Controls, product code JTY).
Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on December 17, 1993, 105 days after receiving the submission on September 3, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2410.
| 510(k) Number | K934330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1993 |
| Decision Date | December 17, 1993 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JTY — Culture Media, For Isolation Of Pathogenic Neisseria |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.2410 |