510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K833724Substantially Equivalent

Enzymatic CO2

American Monitor Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833724 is the FDA 510(k) clearance record for ENZYMATIC CO2, a class II device, cleared for American Monitor Corp. on under FDA product code CIL (Cresol Red Colorimetry, Carbon-Dioxide). FDA records list 73 510(k) clearances for American Monitor Corp., from to . As of , FDA records show no recalls naming K833724.

Clearance record

Decision date
Received
(66 days to decision)
Product code
CIL Cresol Red Colorimetry, Carbon-Dioxide
Regulation
21 CFR 862.1160
Device class
Class II
Review panel
Clinical Chemistry
Applicant
American Monitor Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code CIL

Trailing 12 months

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

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