The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Dfa Respiratory Virus Screening & Id Kit.
| Device ID | K022713 |
| 510k Number | K022713 |
| Device Name: | 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 | James L Brown |
| Correspondent | James L Brown 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 | 2002-08-14 |
| Decision Date | 2002-12-18 |
| Summary: | summary |