Cleared Traditional

K760233 - TABLE, SAMPLE IL 461 (FDA 510(k) Clearance)

Aug 1976
Decision
43d
Days
Class 1
Risk

K760233 is an FDA 510(k) clearance for the TABLE, SAMPLE IL 461. This device is classified as a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I - General Controls, product code JJQ).

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on August 26, 1976, 43 days after receiving the submission on July 14, 1976.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K760233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1976
Decision Date August 26, 1976
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2300