The following data is part of a premarket notification filed by Innovative Diagnostic Systems, Inc. with the FDA for Ids Rapid Ana System.
Device ID | K882960 |
510k Number | K882960 |
Device Name: | IDS RAPID ANA SYSTEM |
Classification | Kit, Anaerobic Identification |
Applicant | INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta, GA 30340 |
Contact | Eriquez, Phd |
Correspondent | Eriquez, Phd INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta, GA 30340 |
Product Code | JSP |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-14 |
Decision Date | 1988-08-12 |