The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification And Typing Kit, Model 01-090000.
| Device ID | K070265 |
| 510k Number | K070265 |
| Device Name: | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 350 WEST STATE ST. Athens, OH 45701 |
| Contact | Gail Goodrum |
| Correspondent | Gail Goodrum DIAGNOSTIC HYBRIDS, INC. 350 WEST STATE ST. Athens, OH 45701 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-29 |
| Decision Date | 2007-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613330738 | K070265 | 000 |
| 30014613330721 | K070265 | 000 |
| 30014613330714 | K070265 | 000 |
| 30014613330707 | K070265 | 000 |