510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K841664Substantially Equivalent

Enzymatic CO2 Diagnostic Chemical

Diagnostic Chemicals, Ltd. (USA), Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841664 is the FDA 510(k) clearance record for ENZYMATIC CO2 DIAGNOSTIC CHEMICAL, a class II device, cleared for Diagnostic Chemicals, Ltd. (Usa) on under FDA product code KHS (Enzymatic, Carbon-Dioxide). FDA records list 77 510(k) clearances for Diagnostic Chemicals, Ltd. (Usa), from to . As of , FDA records show no recalls naming K841664.

Clearance record

Decision date
Received
(46 days to decision)
Product code
KHS Enzymatic, Carbon-Dioxide
Regulation
21 CFR 862.1160
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Chemicals, Ltd. (Usa) 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KHS

Trailing 12 months

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

FDA records show no clearances under product code KHS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHS, 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