Cleared Traditional

K842390 - SYVA IQ 190 DIGITAL PIPETTER DILUTER (FDA 510(k) Clearance)

Jul 1984
Decision
37d
Days
Class 1
Risk

K842390 is an FDA 510(k) clearance for the SYVA IQ 190 DIGITAL PIPETTER DILUTER. 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 July 25, 1984, 37 days after receiving the submission on June 18, 1984.

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

Submission Details

510(k) Number K842390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1984
Decision Date July 25, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
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