K830211 is an FDA 510(k) clearance for the API TB-IDENT*. This device is classified as a Kit, Identification, Mycobacteria (Class I - General Controls, product code JSY).
Submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983, 59 days after receiving the submission on January 24, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K830211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1983 |
| Decision Date | March 24, 1983 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSY — Kit, Identification, Mycobacteria |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |