The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Light Diagnostics Rabies Dfa Reagent.
| Device ID | K972975 |
| 510k Number | K972975 |
| Device Name: | LIGHT DIAGNOSTICS RABIES DFA REAGENT |
| Classification | Antiserum, Fluorescent, Rabies Virus |
| Applicant | LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Cindy D Penny |
| Correspondent | Cindy D Penny LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Product Code | GOI |
| CFR Regulation Number | 866.3460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1998-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252739408 | K972975 | 000 |