CEXClass II
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Clinical Chemistry · 21 CFR 862.1445
MDR events0All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances8All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Data Medical Associates, Inc.Sep 16, 1987
K872891 · LACTATE DEHYDROGENASE ISOENZYME 1
- Seragen Diagnostics, Inc.May 10, 1985
K851521 · LD-1(IMMUNO) SEPARATION SET
- Berwick Medical Products, Inc.Sep 28, 1984
K842018 · ISO-SEP SYSTEM
- Helena LaboratoriesDec 22, 1982
K821983 · TITAN GEL LDH ISOENZYME KIT
- Harleco DiagnosticsJul 14, 1982
K821879 · ULTRACHEM T.P.
- Union Carbide Corp.Feb 13, 1980
K800129 · CENTRIFICHEM CREATININE
- Worthington Biochemical Corp.Jan 24, 1978
K772356 · LDH ISOENZYME COLUMN REAGENT SET
- Bio-Reagents & Diagnostics, Inc.Dec 22, 1977
K771894 · LDH ISOENZYME CONTROL