K843833 is an FDA 510(k) clearance for the BACTERIURIA DETECT DEVICE, MULTI SAMPLER. This device is classified as a Kit, Screening, Urine (Class I - General Controls, product code JXA).
Submitted by Applied Polytechnology, Inc. (Houston, US). The FDA issued a Cleared decision on November 29, 1984, 59 days after receiving the submission on October 1, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K843833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1984 |
| Decision Date | November 29, 1984 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JXA — Kit, Screening, Urine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |