The following data is part of a premarket notification filed by Mrl Diagnostics with the FDA for Hsv-2 Elisa Igg, Model El0920g.
| Device ID | K993724 |
| 510k Number | K993724 |
| Device Name: | HSV-2 ELISA IGG, MODEL EL0920G |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| Applicant | MRL DIAGNOSTICS 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Contact | Michael J Wagner |
| Correspondent | Michael J Wagner MRL DIAGNOSTICS 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Product Code | MYF |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-03 |
| Decision Date | 2000-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816101022193 | K993724 | 000 |
| 20816101022186 | K993724 | 000 |