K843935 is an FDA 510(k) clearance for the MODIFICATION MICROTRAK DIRECT SPECIMEN TEST. This device is classified as a Device, Specimen Collection (Class I - General Controls, product code LIO).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on October 23, 1984, 18 days after receiving the submission on October 5, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K843935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1984 |
| Decision Date | October 23, 1984 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LIO — Device, Specimen Collection |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |