Cleared Traditional

K833505 - IL MODEL 840 MICROPROCESSOR LOADER (FDA 510(k) Clearance)

Jan 1984
Decision
92d
Days
Class 1
Risk

K833505 is an FDA 510(k) clearance for the IL MODEL 840 MICROPROCESSOR LOADER. This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I - General Controls, product code JQW).

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on January 11, 1984, 92 days after receiving the submission on October 11, 1983.

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

Submission Details

510(k) Number K833505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1983
Decision Date January 11, 1984
Days to Decision 92 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