K812078 is an FDA 510(k) clearance for the GONOZYME (10 COPIES FRWD. W/ORIG. TO BG). This device is classified as a Culture Media, For Isolation Of Pathogenic Neisseria (Class II - Special Controls, product code JTY).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 23, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2410.
| 510(k) Number | K812078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | July 23, 1981 |
| Decision Date | July 23, 1981 |
| Days to Decision | — |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTY — Culture Media, For Isolation Of Pathogenic Neisseria |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.2410 |