Cleared Traditional

K792129 - EMIT CLINICAL PROCESSOR-CP 5000 (FDA 510(k) Clearance)

Nov 1979
Decision
20d
Days
Class 1
Risk

K792129 is an FDA 510(k) clearance for the EMIT CLINICAL PROCESSOR-CP 5000. This device is classified as a Calculator/data Processing Module, For Clinical Use (Class I - General Controls, product code JQP).

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 20 days after receiving the submission on October 24, 1979.

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

Submission Details

510(k) Number K792129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1979
Decision Date November 13, 1979
Days to Decision 20 days
Submission Type Traditional
Review Panel Toxicology (TX)
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