The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for D3 Dfa Metapneumovirus Identification Kit.
| Device ID | K090073 |
| 510k Number | K090073 |
| Device Name: | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT |
| Classification | Antisera, Fluorescent, Human Metapneumovirus |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Contact | Gail R Goodrum |
| Correspondent | Gail R Goodrum DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Product Code | OMG |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-12 |
| Decision Date | 2009-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613330530 | K090073 | 000 |
| 30014613330523 | K090073 | 000 |
| 30014613330516 | K090073 | 000 |