The following data is part of a premarket notification filed by Millipore Corporation with the FDA for Light Diagnostics Hsv 1/2 Typing Dfa Kit.
| Device ID | K081527 |
| 510k Number | K081527 |
| Device Name: | LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | MILLIPORE CORPORATION 28820 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Alisha Vu |
| Correspondent | Alisha Vu MILLIPORE CORPORATION 28820 SINGLE OAK DR. Temecula, CA 92590 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2009-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252620638 | K081527 | 000 |
| 04061841047469 | K081527 | 000 |
| 04053252678257 | K081527 | 000 |
| 04053252670930 | K081527 | 000 |
| 04053252278679 | K081527 | 000 |