The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Modification To D3 Ultra Dfa Respiratory Virus Screening & Id Kit.
| Device ID | K092300 |
| 510k Number | K092300 |
| Device Name: | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-29 |
| Decision Date | 2009-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613330479 | K092300 | 000 |
| 30014613330295 | K092300 | 000 |
| 30014613330301 | K092300 | 000 |
| 30014613330318 | K092300 | 000 |
| 30014613330325 | K092300 | 000 |
| 30014613330349 | K092300 | 000 |
| 30014613330356 | K092300 | 000 |
| 30014613330363 | K092300 | 000 |
| 30014613330370 | K092300 | 000 |
| 30014613330387 | K092300 | 000 |
| 30014613330455 | K092300 | 000 |
| 30014613330462 | K092300 | 000 |
| 30014613330288 | K092300 | 000 |