The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Hsv In Situ Dna Probe Hybridization Test Kit.
| Device ID | K911345 |
| 510k Number | K911345 |
| Device Name: | HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT ST. Athens, OH 45701 |
| Contact | James L Brown |
| Correspondent | James 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 | 1991-03-27 |
| Decision Date | 1991-06-17 |