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 |