510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833898Substantially Equivalent

Tri-Level Bilirubin Controls

Sandare Chemical Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833898 is the FDA 510(k) clearance record for TRI-LEVEL BILIRUBIN CONTROLS, a class I device, cleared for Sandare Chemical Co., Inc. on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list 23 510(k) clearances for Sandare Chemical Co., Inc., from to . As of , FDA records show no recalls naming K833898.

Clearance record

Decision date
Received
(60 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sandare Chemical Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

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