510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K053559Substantially Equivalent

Pf4 Enhanced Solid Phase Elisa

Immucor GTI Diagnostics, Inc., Waukesha WI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053559 is the FDA 510(k) clearance record for PF4 ENHANCED SOLID PHASE 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 2 recalls naming K053559.

Clearance record

Decision date
Received
(30 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 20925 Crossroads Cir., Waukesha WI
510(k) summary
Summary PDF
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