The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Elvis Hsv.
| Device ID | K941924 |
| 510k Number | K941924 |
| Device Name: | ELVIS HSV |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT ST. Athens, OH 45701 |
| Contact | J. L Brown |
| Correspondent | J. L Brown DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT 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 | 1994-04-20 |
| Decision Date | 1995-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613336310 | K941924 | 000 |
| 30014613336303 | K941924 | 000 |
| 30014613336297 | K941924 | 000 |
| 30014613336280 | K941924 | 000 |
| 30014613336020 | K941924 | 000 |
| 30014613336013 | K941924 | 000 |