510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821374Substantially Equivalent

Enzymune-Test Insulin

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

K821374 is the FDA 510(k) clearance record for ENZYMUNE-TEST INSULIN, a class I device, cleared for Icl Scientific on under FDA product code CFP (Radioimmunoassay, Immunoreactive Insulin). FDA records list 48 510(k) clearances for Icl Scientific, from to . As of , FDA records show no recalls naming K821374.

Clearance record

Decision date
Received
(18 days to decision)
Product code
CFP Radioimmunoassay, Immunoreactive Insulin
Regulation
21 CFR 862.1405
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Icl Scientific 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CFP

Trailing 12 months

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

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