JHFClass II
Colorimetric Method, Lecithin/sphingomyelin Ratio
Clinical Chemistry · 21 CFR 862.1455
MDR events4All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances2All time
Recent MDR events
4 adverse event reports on file
- TRIAGE PROFILER SOB 25 TEST KITJun 29, 2009MalfunctionBiosite Incorporated2027969-2009-00511
- TRIAGE PROFILER SOB 25 TEST KITJun 29, 2009MalfunctionBiosite Incorporated2027969-2009-00513
- TRIAGE PROFILER SOB 25 TEST KITJun 29, 2009MalfunctionBiosite Incorporated2027969-2009-00512
- TDX/TDXFLX FLM IIAug 3, 2007OtherAbbott Laboratories1415939-2007-00205
Event type breakdown
Malfunction3
Other1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
2 clearances for this product code