Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
Clinical Chemistry · 21 CFR 862.2400
Recent MDR events
46 adverse event reports on file
- AFINION AS100 ANALYZER US VERSIONJun 30, 2026MalfunctionAbbott Diagnostics Technologies As9613069-2026-00002
- ABBOTT AFINION 2Mar 24, 2026MalfunctionAbbott Diagnostics Technologies As9613069-2026-00001
- AFINION AS100 ANALYZER US VERSION RFBDec 4, 2025MalfunctionAbbott Diagnostics Technologies As9613069-2025-00005
- ALERE AFINION AS100 ANALYZERAug 6, 2025MalfunctionAbbott Diagnostics Technologies As9613069-2025-00004
- AFINION 2Apr 22, 2025MalfunctionAbbott Diagnostics Technologies As9613069-2025-00003
- AFINION 2Mar 12, 2025MalfunctionAbbott Diagnostics Technologies As9613069-2025-00002
- ALERE AFINION AS100 ANALYZERMar 4, 2025MalfunctionAbbott Diagnostics Technologies As9613069-2025-00001
- AFINION 2Oct 25, 2024MalfunctionAbbott Diagnostics Technologies As9613069-2024-00005
- AFINION 2, NOROct 22, 2024MalfunctionAbbott Diagnostics Technologies As9613069-2024-00004
- AFINION 2Jun 20, 2024MalfunctionAbbott Diagnostics Technologies As9613069-2024-00002
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
23 firms currently registered for this product code
Nova Biomedical Corporation
WALTHAM, MA, US
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Abbott Diagnostics Technologies As
Oslo, NO
Nova Biomedical Corporation
Billerica, MA, US
Viramed Biotech Ag
PLANEGG Bavaria, DE
Precision Biosensor Inc. 2nd Factory
Yuseong-gu Daejeon, KR
Alere San Diego, Inc.
San Diego, CA, US
Ucp Biosciences, Inc.
Milpitas, CA, US
Sebia
EVRY Essonne, FR
Schiller Ag
BAAR Zug, CH
Infitek Co., Ltd.
Shanghai, CN
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Nano-ditech Corporation
Cranbury, NJ, US
Premier Biotech, Llc
Minneapolis, MN, US
Helena Laboratories, Corp.
BEAUMONT, TX, US
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Sanmina-sci Ab
SJALEVAD Vasternorrland, SE
510(k) clearances
18 clearances for this product code
- Arlington Scientific, Inc.Nov 9, 2011
K111356 · ASIMANAGER - AT
- Isolab, Inc.Nov 17, 1994
K944185 · ISOSCAN
- Ciba Corning Diagnostics Corp.Feb 18, 1992
K915332 · MODEL 795 FLUOROMETER/DENSITOMETER
- V-Tech, Inc.Jan 27, 1989
K885254 · TARGET READER
- Helena LaboratoriesDec 17, 1986
K860645 · ELECTROPHORESIS DATA CENTER (EDC)
- Hybritech, Inc.Aug 19, 1986
K862956 · ICON READER
- Astral Medical SystemsSep 25, 1985
K853734 · APOLLO DENSITOMETER
- Astral Medical SystemsMay 13, 1985
K851154 · ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18