The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Diagnostic Hybrids D3 Dfa Varicella-zoster Virus Identification Kit, 01-020000.
| Device ID | K070206 |
| 510k Number | K070206 |
| Device Name: | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 |
| Classification | Antigen, Cf, (including Cf Control), Varicella-zoster |
| 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 | GQW |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-22 |
| Decision Date | 2007-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613330509 | K070206 | 000 |
| 30014613330493 | K070206 | 000 |