The following data is part of a premarket notification filed by Innovative Diagnostic Systems, Inc. with the FDA for Ids Staphylochrome Test.
| Device ID | K822144 |
| 510k Number | K822144 |
| Device Name: | IDS STAPHYLOCHROME TEST |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta, GA 30340 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-21 |
| Decision Date | 1982-08-24 |