Cleared Traditional

K771604 - SPECTROPHOTOMETEO IL MODEL 651 (FDA 510(k) Clearance)

Sep 1977
Decision
31d
Days
Class 1
Risk

K771604 is an FDA 510(k) clearance for the SPECTROPHOTOMETEO IL MODEL 651. 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 September 22, 1977, 31 days after receiving the submission on August 22, 1977.

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

Submission Details

510(k) Number K771604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1977
Decision Date September 22, 1977
Days to Decision 31 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary

Device Classification

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