The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Ctapi - Neissera Screen.
Device ID | K850982 |
510k Number | K850982 |
Device Name: | CTAPI - NEISSERA SCREEN |
Classification | Culture Media, Multiple Biochemical Test |
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 | JSE |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-11 |
Decision Date | 1985-03-29 |