The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for D3 Fastpoint L-dfa Influenza A/influenza B Virus Identification Kit.
| Device ID | K092882 |
| 510k Number | K092882 |
| Device Name: | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT |
| Classification | Antisera, Cf, Influenza Virus A, B, C |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Contact | Ronald H Lollar |
| Correspondent | Ronald H Lollar DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Product Code | GNW |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-18 |
| Decision Date | 2009-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613330806 | K092882 | 000 |
| 30014613330790 | K092882 | 000 |
| 30014613330783 | K092882 | 000 |