The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Elvis Hsv Id/typing Test System.
| Device ID | K971662 |
| 510k Number | K971662 |
| Device Name: | ELVIS HSV ID/TYPING TEST SYSTEM |
| 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 | 1997-04-29 |
| Decision Date | 1997-11-18 |
| Summary: | summary |