Cleared Traditional

K831273 - QST TM SAMPLE PROCESSOR (FDA 510(k) Clearance)

Jun 1983
Decision
44d
Days
Class 1
Risk

K831273 is an FDA 510(k) clearance for the QST TM SAMPLE PROCESSOR. This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I - General Controls, product code JQW).

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983, 44 days after receiving the submission on April 19, 1983.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K831273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1983
Decision Date June 02, 1983
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JQW — Station, Pipetting And Diluting, For Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2750