The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Modification Micro-mic.
Device ID | K884510 |
510k Number | K884510 |
Device Name: | MODIFICATION MICRO-MIC |
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 |