The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Herpes Group Igg Elisa Test System.
| Device ID | K963645 |
| 510k Number | K963645 |
| Device Name: | HERPES GROUP IGG ELISA TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | ARMKEL, LLC. 1306F BAILES LN. Frederick, MD 21701 |
| Contact | William L Boteler, Jr. |
| Correspondent | William L Boteler, Jr. ARMKEL, LLC. 1306F BAILES LN. Frederick, MD 21701 |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-12 |
| Decision Date | 1997-02-04 |
| Summary: | summary |