The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Modification To Api Uniscept 20gp.
| Device ID | K901559 |
| 510k Number | K901559 |
| Device Name: | MODIFICATION TO API UNISCEPT 20GP |
| Classification | Gram Positive Identification Panel |
| Applicant | ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Contact | Valerie L Vargo |
| Correspondent | Valerie L Vargo ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Product Code | LQL |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-03 |
| Decision Date | 1990-09-10 |