510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983379Substantially Equivalent

Gti-Pf4 Elisa

Immucor GTI Diagnostics, Inc., Brookfield WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983379 is the FDA 510(k) clearance record for GTI-PF4 ELISA, a class II device, cleared for Genetic Testing Institute on under FDA product code LCO (Platelet Factor 4 Radioimmunoassay). FDA records list 8 510(k) clearances for Immucor GTI Diagnostics, Inc., from to . As of , FDA records show no recalls naming K983379.

Clearance record

Decision date
Received
(165 days to decision)
Product code
LCO Platelet Factor 4 Radioimmunoassay
Regulation
21 CFR 864.7695
Device class
Class II
Review panel
Hematology
Applicant
Genetic Testing Institute 150 N. Patrick Blvd., Brookfield WI
510(k) summary
Statement
Third party review
No

Clearances, product code LCO

Trailing 12 months

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

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