Atlas FDA

LCO

13 FDA 510(k) clearances · Product code

92 daysmedian time to decision
170 days90th percentile
13clearances measured

FDA profile

Official device name
Platelet Factor 4 Radioimmunoassay
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7695
Medical specialty
Hematology
Flags
Third-party review eligible
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
HemosIL CL HIT-IgG(PF4-H) (K243374)Instrumentation Laboratory (IL) Co.2025-01-28
PF4 Enhanced assay (K201570)Immucor Gti Diagnostics, Inc.2020-09-11
PF4 IgG assay (K201311)Immucor Gti Diagnostics, Inc.2020-06-18
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls (K170854)Instrumentation Laboratory CO2017-09-08
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls (K153137)Instrumentation Laboratory CO2016-07-08
PF4 IGG (K071781)Genetic Testing Institute2007-12-19
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (K071255)Hyphen Biomed2007-09-07
PF4 ENHANCED SOLID PHASE ELISA (K053559)Genetic Testing Institute2006-01-20
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY (K040293)Akers Laboratories, Inc.2004-05-28
ASSERACHROM HPIA TEST KIT (K003767)Diagnostica Stago, Inc.2001-02-12
GTI-PF4 ELISA (K983379)Genetic Testing Institute1999-03-09
ENZYGNOST PLATELET FACTOR 4 (PF4) KIT (K890633)Behring Diagnostics, Inc.1989-04-21
ASSERACHROM PF4 KIT (K862774)American Bioproducts Co.1986-09-04

Track LCO automatically

Every clearance here is in the API, with alerts when new ones post.