The following data is part of a premarket notification filed by Innovative Diagnostic Systems, Inc. with the FDA for Ids Rapid Cb Plus System.
Device ID | K962966 |
510k Number | K962966 |
Device Name: | IDS RAPID CB PLUS SYSTEM |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 2797 PETERSON PLACE Norcross, GA 30071 |
Contact | Louis A Eriquez |
Correspondent | Louis A Eriquez INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 2797 PETERSON PLACE Norcross, GA 30071 |
Product Code | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-30 |
Decision Date | 1996-10-08 |