The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Api Uniscept Kb/type 2 And 3.
| Device ID | K922926 |
| 510k Number | K922926 |
| Device Name: | API UNISCEPT KB/TYPE 2 AND 3 |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Contact | Ann W Sisalli |
| Correspondent | Ann W Sisalli ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-17 |
| Decision Date | 1992-10-13 |