The following data is part of a premarket notification filed by Bartels & Stout, Inc. with the FDA for Test Kit For Detection Of Herpes Simplex.
| Device ID | K802526 |
| 510k Number | K802526 |
| Device Name: | TEST KIT FOR DETECTION OF HERPES SIMPLEX |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | BARTELS & STOUT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1981-02-09 |