Cleared Traditional

K771337 - I.L. MODEL 643 FLAME PHOTOMETER (FDA 510(k) Clearance)

Oct 1977
Decision
91d
Days
Class 1
Risk

K771337 is an FDA 510(k) clearance for the I.L. MODEL 643 FLAME PHOTOMETER. This device is classified as a Flame Emission Photometer For Clinical Use (Class I - General Controls, product code JJO).

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on October 18, 1977, 91 days after receiving the submission on July 19, 1977.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2540.

Submission Details

510(k) Number K771337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1977
Decision Date October 18, 1977
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JJO — Flame Emission Photometer For Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2540