The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Light Diagnostics Simulfluor Flu A/flu B.
| Device ID | K974302 |
| 510k Number | K974302 |
| Device Name: | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B |
| Classification | Antisera, Cf, Influenza Virus A, B, C |
| Applicant | LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Cindy Penny |
| Correspondent | Cindy Penny LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Product Code | GNW |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-17 |
| Decision Date | 1998-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252367588 | K974302 | 000 |
| 04053252368165 | K974302 | 000 |
| 04053252270239 | K974302 | 000 |