Cleared Traditional

K842042 - IL 1312, PH BLOOD GAS MANAGER (FDA 510(k) Clearance)

Jul 1984
Decision
51d
Days
Risk

K842042 is an FDA 510(k) clearance for the IL 1312, PH BLOOD GAS MANAGER..

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on July 11, 1984, 51 days after receiving the submission on May 21, 1984.

This device falls under the Chemistry FDA review panel.

Submission Details

510(k) Number K842042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1984
Decision Date July 11, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code
Device Class