The following data is part of a premarket notification filed by Millipore Corporation with the FDA for Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124.
| Device ID | K093815 |
| 510k Number | K093815 |
| Device Name: | LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 |
| Classification | Antisera, Fluorescent, Human Metapneumovirus |
| Applicant | MILLIPORE CORPORATION 28820 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Catherine Karaman |
| Correspondent | Catherine Karaman MILLIPORE CORPORATION 28820 SINGLE OAK DR. Temecula, CA 92590 |
| Product Code | OMG |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-14 |
| Decision Date | 2010-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252282133 | K093815 | 000 |
| 04053252518584 | K093815 | 000 |
| 04061841047452 | K093815 | 000 |
| 04053252279362 | K093815 | 000 |