510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820714Substantially Equivalent

Dow Bilirubin(direct) Determination

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

K820714 is the FDA 510(k) clearance record for DOW BILIRUBIN(DIRECT) DETERMINATION, a class II device, cleared for The Dow Chemical Co. on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 26 510(k) clearances for The Dow Chemical Co., from to . As of , FDA records show no recalls naming K820714.

Clearance record

Decision date
Received
(17 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
The Dow Chemical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CIG

Trailing 12 months
1 clearance under product code CIG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260