510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823535Substantially Equivalent

Diluent, Zeroing Solution & Co-Ox/ise

Shaban Mfg. Co., MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823535 is the FDA 510(k) clearance record for DILUENT, ZEROING SOLUTION & CO-OX/ISE, a class I device, cleared for Shaban Mfg. Co. on under FDA product code JKT (Gas Chromatograph, Carbon-Monoxide). FDA records list 35 510(k) clearances for Shaban Mfg. Co., from to . As of , FDA records show no recalls naming K823535.

Clearance record

Decision date
Received
(59 days to decision)
Product code
JKT Gas Chromatograph, Carbon-Monoxide
Regulation
21 CFR 862.3220
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Shaban Mfg. Co.
Third party review
No

Clearances, product code JKT

Trailing 12 months

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

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