Cleared Traditional

K780521 - SPECTROPHOTOMETER, ATOMIC ABSORPTION (FDA 510(k) Clearance)

May 1978
Decision
42d
Days
Class 1
Risk

K780521 is an FDA 510(k) clearance for the SPECTROPHOTOMETER, ATOMIC ABSORPTION. 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 May 12, 1978, 42 days after receiving the submission on March 31, 1978.

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

Submission Details

510(k) Number K780521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1978
Decision Date May 12, 1978
Days to Decision 42 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