The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Quad Ferm +.
| Device ID | K853544 |
| 510k Number | K853544 |
| Device Name: | QUAD FERM + |
| Classification | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Contact | Susan D Tiedy |
| Correspondent | Susan D Tiedy ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview , NY 11803 - |
| Product Code | JSX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1985-09-05 |