Medical Device Manufacturer · US , Mchenry , IL

Amersham Corp.

94 submissions · 94 cleared · Since 1976
94
Total
94
Cleared
0
Denied

Amersham Corp. — FDA 510(k) Submissions

Amersham Corp. has submitted 94 FDA 510(k) premarket notifications since 1976, of which 94 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Total Triiodothyronine, Multi-analyte Controls, All Kinds (assayed), Ferritin, Antigen, Antiserum, Control, Radioimmunoassay, Free Thyroxine, Radioimmunoassay, Thyroid-stimulating Hormone . Use the specialty filter in the sidebar to narrow results.

94 devices
1–25 of 94
AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
K914135 · CFT Radioimmunoassay,... · Chemistry
Feb 1992 155d
AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
K912733 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jul 1991 32d
AMERLITE CK-MB ASSAY
K912766 · JHY Colorimetric Method, Cpk... · Chemistry
Jul 1991 23d
AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
K904666 · JLW Radioimmunoassay,... · Chemistry
Nov 1990 18d
AMERSHAM TSH CONTROL SERA
K902760 · JJX Single (specified)... · Chemistry
Jul 1990 32d
GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415
K901832 · KGI Densitometer, Bone · Radiology
Jul 1990 76d
GADOLINIUM-153 BONE DENSITOMETER SOURCES
K901848 · KGI Densitometer, Bone · Radiology
Jul 1990 76d
GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)
K901854 · KGI Densitometer, Bone · Radiology
Jul 1990 76d
GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)
K901857 · KGI Densitometer, Bone · Radiology
Jul 1990 76d
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
K896270 · CHP Radioimmunoassay, Estradiol · Chemistry
Dec 1989 42d
LAN.0800Q/2800Q
K895872 · DBF Ferritin, Antigen,... · Immunology
Oct 1989 13d
CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD
K894409 · IWA Source, Wire, Iridium,... · Radiology
Sep 1989 74d
RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
K894329 · JJX Single (specified)... · Chemistry
Sep 1989 53d
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
K893469 · CEE Radioimmunoassay,... · Toxicology
Aug 1989 103d
AMERLEX-MAB FT4 KIT
K894091 · CEC Radioimmunoassay, Free... · Chemistry
Aug 1989 55d
ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)
K893036 · LRM Anti-dna Antibody... · Immunology
Jun 1989 39d
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · DBF Ferritin, Antigen,... · Immunology
May 1989 33d
AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)
K890708 · JJY Multi-analyte Controls,... · Chemistry
Mar 1989 48d
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)
K890414 · JJY Multi-analyte Controls,... · Chemistry
Mar 1989 50d
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT
K885195 · CDP Radioimmunoassay, Total... · Chemistry
Feb 1989 54d
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
K890191 · IWJ System, Applicator,... · Radiology
Feb 1989 19d
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT
K883123 · CEC Radioimmunoassay, Free... · Chemistry
Dec 1988 149d
AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)
K884105 · CHP Radioimmunoassay, Estradiol · Chemistry
Nov 1988 48d
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100 · JLS Radioimmunoassay,... · Chemistry
Nov 1988 43d
AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)
K883878 · CFT Radioimmunoassay,... · Chemistry
Nov 1988 49d

Looking for a specific device from Amersham Corp.? Search by device name or K-number.

Search all Amersham Corp. devices
Filters