Cleared Traditional

TRACE ANALYTICAL REDUCTION GAS ANALYZ

K820025 · Trace Analytical · Toxicology

Feb 1982

Decision

41d

Days

Class 1

Risk

About This 510(k) Submission

K820025 is an FDA 510(k) clearance for the TRACE ANALYTICAL REDUCTION GAS ANALYZ, a Chromatography(gas), Clinical Use (Class I — General Controls, product code KZQ), submitted by Trace Analytical (Mchenry, US). The FDA issued a Cleared decision on February 15, 1982, 41 days after receiving the submission on January 5, 1982. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2250.

Submission Details

510(k) Number	K820025 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 1982
Decision Date	February 15, 1982
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—