The following data is part of a premarket notification filed by Boots-celltech Diagnostics, Inc. with the FDA for Ideia Herpes Simplex Virus Test.
| Device ID | K871877 |
| 510k Number | K871877 |
| Device Name: | IDEIA HERPES SIMPLEX VIRUS TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Contact | Stephen Abbott |
| Correspondent | Stephen Abbott BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-14 |
| Decision Date | 1989-11-17 |