K822144 is an FDA 510(k) clearance for the IDS STAPHYLOCHROME TEST. This device is classified as a Kit, Screening, Staphylococcus Aureus (Class I - General Controls, product code JWX).
Submitted by Innovative Diagnostic Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on August 24, 1982, 34 days after receiving the submission on July 21, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K822144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1982 |
| Decision Date | August 24, 1982 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JWX — Kit, Screening, Staphylococcus Aureus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |