The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Modification Mic/api Uniscept(r).
| Device ID | K884509 |
| 510k Number | K884509 |
| Device Name: | MODIFICATION MIC/API UNISCEPT(R) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Contact | Louise Horzempa |
| Correspondent | Louise Horzempa 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 | 1988-10-27 |
| Decision Date | 1988-11-22 |