The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Api Uniscept Kb.
| Device ID | K843733 |
| 510k Number | K843733 |
| Device Name: | API UNISCEPT KB |
| Classification | Susceptibility Test Cards, Antimicrobial |
| Applicant | ANALYTICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LTW |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-24 |
| Decision Date | 1984-10-24 |