510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K832003Substantially Equivalent

Aqueous Blood Gas Control Level i,ii &

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

K832003 is the FDA 510(k) clearance record for AQUEOUS BLOOD GAS CONTROL LEVEL I,II &, a class I device, cleared for American Dade on under FDA product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)). FDA records list 149 510(k) clearances for American Dade, from to . As of , FDA records show no recalls naming K832003.

Clearance record

Decision date
Received
(49 days to decision)
Product code
JJS Controls For Blood-Gases, (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
American Dade 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JJS

Trailing 12 months

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

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