510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820025Substantially Equivalent

Trace Analytical Reduction Gas Analyz

Trace Analytical, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820025 is the FDA 510(k) clearance record for TRACE ANALYTICAL REDUCTION GAS ANALYZ, a class I device, cleared for Trace Analytical on under FDA product code KZQ (Chromatography(Gas), Clinical Use). FDA records list one 510(k) clearance for Trace Analytical. As of , FDA records show no recalls naming K820025.

Clearance record

Decision date
Received
(41 days to decision)
Product code
KZQ Chromatography(Gas), Clinical Use
Regulation
21 CFR 862.2250
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Trace Analytical 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KZQ

Trailing 12 months

FDA records hold no clearances under product code KZQ in the trailing twelve months.

FDA records show no clearances under product code KZQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260