K820483 is an FDA 510(k) clearance for the IDA RAPID O2A SYSTEM. This device is classified as a Kit, Anaerobic Identification (Class I - General Controls, product code JSP).
Submitted by Innovative Diagnostic Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on March 15, 1982, 21 days after receiving the submission on February 22, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K820483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 1982 |
| Decision Date | March 15, 1982 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSP — Kit, Anaerobic Identification |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |