510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K830469Substantially Equivalent

Bilirubin Standard-Lyophilized

Dow Instruments & Reagents, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830469 is the FDA 510(k) clearance record for BILIRUBIN STANDARD-LYOPHILIZED, a class II device, cleared for Dow Instruments & Reagents, Inc. on under FDA product code JIT (Calibrator, Secondary). FDA records list 2 510(k) clearances for Dow Instruments & Reagents, Inc., from to . As of , FDA records show no recalls naming K830469.

Clearance record

Decision date
Received
(37 days to decision)
Product code
JIT Calibrator, Secondary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Dow Instruments & Reagents, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JIT

Trailing 12 months

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

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