K972975 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS RABIES DFA REAGENT. This device is classified as a Antiserum, Fluorescent, Rabies Virus (Class II - Special Controls, product code GOI).
Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on December 22, 1998, 498 days after receiving the submission on August 11, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3460.
| 510(k) Number | K972975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1997 |
| Decision Date | December 22, 1998 |
| Days to Decision | 498 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GOI — Antiserum, Fluorescent, Rabies Virus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3460 |