Cleared Traditional

K760119 - SAMPLER, FLAMELESS (IL MODEL 555) (FDA 510(k) Clearance)

Jul 1976
Decision
25d
Days
Class 1
Risk

K760119 is an FDA 510(k) clearance for the SAMPLER, FLAMELESS (IL MODEL 555). This device is classified as a Atomic Absorption Spectrophotometer, General Use (Class I - General Controls, product code JXR).

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976, 25 days after receiving the submission on June 25, 1976.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2850.

Submission Details

510(k) Number K760119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1976
Decision Date July 20, 1976
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JXR — Atomic Absorption Spectrophotometer, General Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2850