LCO · Class II · 21 CFR 864.7695

FDA Product Code LCO: Platelet Factor 4 Radioimmunoassay

Leading manufacturers include Instrumentation Laboratory CO.

2
Total
2
Cleared
211d
Avg days
2016
Since

List of Platelet Factor 4 Radioimmunoassay devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Sep 08, 2017
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
K170854
Instrumentation Laboratory CO
Hematology · 170d
Cleared Jul 08, 2016
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
K153137
Instrumentation Laboratory CO
Hematology · 252d

How to use this database

This page lists all FDA 510(k) submissions for Platelet Factor 4 Radioimmunoassay devices (product code LCO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Hematology FDA review panel. Browse all Hematology devices →