The following data is part of a premarket notification filed by Euroimmun Us Llc with the FDA for Euroimmun Anti-hsv-2 Elisa (igg) And Anti-hsv-1 Elisa (igg) Kit.
| Device ID | K061239 |
| 510k Number | K061239 |
| Device Name: | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| Applicant | EUROIMMUN US LLC 429 ROCKAWAY VALLEY ROAD UNIT 1200 Boonton Township, NJ 07005 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US LLC 429 ROCKAWAY VALLEY ROAD UNIT 1200 Boonton Township, NJ 07005 |
| Product Code | MYF |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-03 |
| Decision Date | 2007-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016096733 | K061239 | 000 |
| 04049016096726 | K061239 | 000 |