Cleared Traditional

K770645 - SPECTROPHOTOMETER, MODEL 751 (FDA 510(k) Clearance)

Jun 1977
Decision
80d
Days
Class 1
Risk

K770645 is an FDA 510(k) clearance for the SPECTROPHOTOMETER, MODEL 751. 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 June 24, 1977, 80 days after receiving the submission on April 5, 1977.

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

Submission Details

510(k) Number K770645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1977
Decision Date June 24, 1977
Days to Decision 80 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