The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for D3 Ultra Dfa Respiratory Virus Screening & Id Kit.
| Device ID | K061101 |
| 510k Number | K061101 |
| Device Name: | D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT |
| Classification | Antisera, Cf, Influenza Virus A, B, C |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 350 WEST STATE ST. Athens, OH 45701 |
| Contact | Gail R Goodrum |
| Correspondent | Gail R Goodrum DIAGNOSTIC HYBRIDS, INC. 350 WEST STATE ST. 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 | 2006-04-20 |
| Decision Date | 2006-11-20 |
| Summary: | summary |