Cleared Traditional

K894069 - ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER (FDA 510(k) Clearance)

Aug 1989
Decision
74d
Days
Class 1
Risk

K894069 is an FDA 510(k) clearance for the ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER. This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I - General Controls, product code JQW).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 21, 1989, 74 days after receiving the submission on June 8, 1989.

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

Submission Details

510(k) Number K894069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1989
Decision Date August 21, 1989
Days to Decision 74 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