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 |