Cleared Traditional

K790543 - THE ABBOTT EXECUTIVE (FDA 510(k) Clearance)

May 1979
Decision
42d
Days
Class 1
Risk

K790543 is an FDA 510(k) clearance for the THE ABBOTT EXECUTIVE. This device is classified as a Calculator/data Processing Module, For Clinical Use (Class I - General Controls, product code JQP).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 3, 1979, 42 days after receiving the submission on March 22, 1979.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number K790543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1979
Decision Date May 03, 1979
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JQP — Calculator/data Processing Module, For Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2100