The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Elvis Hsv Id And D3 Typing Test System.
| Device ID | K091753 |
| 510k Number | K091753 |
| Device Name: | ELVIS HSV ID AND D3 TYPING TEST SYSTEM |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Contact | Ronald H Lollar |
| Correspondent | Ronald H Lollar DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613336334 | K091753 | 000 |
| 30014613332985 | K091753 | 000 |
| 30014613332992 | K091753 | 000 |
| 30014613333005 | K091753 | 000 |
| 30014613333012 | K091753 | 000 |
| 30014613333029 | K091753 | 000 |
| 30014613333036 | K091753 | 000 |
| 30014613333043 | K091753 | 000 |
| 30014613333050 | K091753 | 000 |
| 30014613333067 | K091753 | 000 |
| 30014613333074 | K091753 | 000 |
| 30014613333081 | K091753 | 000 |
| 30014613333098 | K091753 | 000 |
| 30014613330158 | K091753 | 000 |
| 30014613330165 | K091753 | 000 |
| 30014613330196 | K091753 | 000 |
| 30014613330202 | K091753 | 000 |
| 30014613336327 | K091753 | 000 |
| 30014613332978 | K091753 | 000 |