The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for D3 Ultra Duet Dfa Respiratory Virus Identification Kit.
| Device ID | K091171 |
| 510k Number | K091171 |
| Device Name: | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT |
| Classification | Antisera, Fluorescent, Human Metapneumovirus |
| 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 | OMG |
| Subsequent Product Code | GNS |
| Subsequent Product Code | GNY |
| Subsequent Product Code | GQS |
| Subsequent Product Code | LKT |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-22 |
| Decision Date | 2009-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613330844 | K091171 | 000 |
| 30014613330776 | K091171 | 000 |
| 30014613330769 | K091171 | 000 |
| 30014613330752 | K091171 | 000 |
| 30014613330875 | K091171 | 000 |
| 30014613330868 | K091171 | 000 |
| 30014613330851 | K091171 | 000 |