K954784 is an FDA 510(k) clearance for the DRYSIDE NEISSERIA. This device is classified as a Test Reagents, Neisseria Gonorrhoeae Biochemical (Class I - General Controls, product code LTS).
Submitted by Difco Laboratories, Inc. (Livouia, US). The FDA issued a Cleared decision on January 30, 1996, 105 days after receiving the submission on October 17, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K954784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1995 |
| Decision Date | January 30, 1996 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LTS — Test Reagents, Neisseria Gonorrhoeae Biochemical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |