510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802035Substantially Equivalent

Baker Diag. Ultrarate CO2 Reagent Kit

J.T. Baker Chemical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802035 is the FDA 510(k) clearance record for BAKER DIAG. ULTRARATE CO2 REAGENT KIT, a class II device, cleared for J.T. Baker Chemical Co. on under FDA product code JFL (Ph Rate Measurement, Carbon-Dioxide). FDA records list 54 510(k) clearances for J.T. Baker Chemical Co., from to . As of , FDA records show no recalls naming K802035.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JFL Ph Rate Measurement, Carbon-Dioxide
Regulation
21 CFR 862.1160
Device class
Class II
Review panel
Clinical Chemistry
Applicant
J.T. Baker Chemical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JFL

Trailing 12 months

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

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