The following data is part of a premarket notification filed by Microscan Div. Baxter Healthcare Corp. with the FDA for Herpes Simplex Antibody Test For Dect. Of Hsv 1&2.
| Device ID | K870814 |
| 510k Number | K870814 |
| Device Name: | HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento, CA 95691 |
| Contact | Lorraine Weaver |
| Correspondent | Lorraine Weaver MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento, CA 95691 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-06-04 |