K871687 is an FDA 510(k) clearance for the TYTEM(R) REAGENT DISPENSER. This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I - General Controls, product code JQW).
Submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on May 20, 1987, 21 days after receiving the submission on April 29, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2750.
| 510(k) Number | K871687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1987 |
| Decision Date | May 20, 1987 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQW — Station, Pipetting And Diluting, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2750 |