510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K761027Substantially Equivalent

Auto-Total Bilirubin Reag for Gilford an

Harleco, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K761027 is the FDA 510(k) clearance record for AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN, a class II device, cleared for Harleco on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 116 510(k) clearances for Harleco, from to . As of , FDA records show no recalls naming K761027.

Clearance record

Decision date
Received
(18 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Harleco 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