510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790059Substantially Equivalent

Proactivator C3, C4 and C3

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

K790059 is the FDA 510(k) clearance record for PROACTIVATOR C3, C4 AND C3, a class II device, cleared for Icl Scientific on under FDA product code KTP (Complement C3b Activator Immunoassay Reagents). FDA records list 48 510(k) clearances for Icl Scientific, from to . As of , FDA records show no recalls naming K790059.

Clearance record

Decision date
Received
(65 days to decision)
Product code
KTP Complement C3b Activator Immunoassay Reagents
Regulation
21 CFR 866.5260
Device class
Class II
Review panel
Immunology
Applicant
Icl Scientific 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KTP

Trailing 12 months

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

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