Amersham Corp.
Mchenry, IL, US
Amersham Corp. appears in FDA device records in Mchenry, IL. FDA records list 94 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 94
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 94FDA records hold 94 510(k) clearances for Amersham Corp. between 1976 and 1992. The busiest year on record is 1988, with 19. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 3 |
| 1978 | 4 |
| 1979 | 4 |
| 1980 | 13 |
| 1981 | 8 |
| 1982 | 3 |
| 1983 | 1 |
| 1984 | 5 |
| 1985 | 4 |
| 1986 | 3 |
| 1987 | 3 |
| 1988 | 19 |
| 1989 | 12 |
| 1990 | 6 |
| 1991 | 2 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K914135 | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 | CFT | Substantially Equivalent | |
| K912733 | AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT | CIG | Substantially Equivalent | |
| K912766 | AMERLITE CK-MB ASSAY | JHY | Substantially Equivalent | |
| K904666 | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 | JLW | Substantially Equivalent | |
| K902760 | AMERSHAM TSH CONTROL SERA | JJX | Substantially Equivalent | |
| K901857 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) | KGI | Substantially Equivalent | |
| K901854 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) | KGI | Substantially Equivalent | |
| K901848 | GADOLINIUM-153 BONE DENSITOMETER SOURCES | KGI | Substantially Equivalent | |
| K901832 | GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 | KGI | Substantially Equivalent | |
| K896270 | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 | CHP | Substantially Equivalent | |
| K895872 | LAN.0800Q/2800Q | DBF | Substantially Equivalent | |
| K894409 | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD | IWA | Substantially Equivalent | |
| K894329 | RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL | JJX | Substantially Equivalent | |
| K893469 | AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT | CEE | Substantially Equivalent | |
| K894091 | AMERLEX-MAB FT4 KIT | CEC | Substantially Equivalent | |
| K893036 | ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) | LRM | Substantially Equivalent | |
| K892362 | AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) | DBF | Substantially Equivalent | |
| K890708 | AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) | JJY | Substantially Equivalent | |
| K890414 | RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109) | JJY | Substantially Equivalent | |
| K885195 | AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT | CDP | Substantially Equivalent | |
| K890191 | HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN | IWJ | Substantially Equivalent | |
| K883123 | AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT | CEC | Substantially Equivalent | |
| K884105 | AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) | CHP | Substantially Equivalent | |
| K884100 | AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 | JLS | Substantially Equivalent | |
| K883878 | AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) | CFT | Substantially Equivalent | |
| K882736 | AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA | JJY | Substantially Equivalent | |
| K882728 | AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190 | JJY | Substantially Equivalent | |
| K882475 | AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200 | LFX | Substantially Equivalent | |
| K883124 | AMERLITE FREE THYROID CONTROL SERA LAN.4002 | JJY | Substantially Equivalent | |
| K882907 | AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT | JLW | Substantially Equivalent | |
| K882727 | AMERLITE TOTAL THYROID CONTROL SERA LAN.4001 | JJY | Substantially Equivalent | |
| K880933 | AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST | CEP | Substantially Equivalent | |
| K881142 | AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST | CGJ | Substantially Equivalent | |
| K881355 | AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT | JHI | Substantially Equivalent | |
| K880823 | AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT | KXT | Substantially Equivalent | |
| K881373 | AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT | CDP | Substantially Equivalent | |
| K880934 | MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT | JLS | Substantially Equivalent | |
| K880687 | CORTISOL ENHANCED LUMINESCENCE ASSAY KIT | CGR | Substantially Equivalent | |
| K874362 | AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 | KHQ | Substantially Equivalent | |
| K874203 | AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800 | DBF | Substantially Equivalent | |
| K873976 | AMERLITE TT4 ASSAY (240/480/144 TEST KITS) | KLI | Substantially Equivalent | |
| K873858 | AMERLITE TT3 ASSAY, LAN.0003/1003/2003 | CDP | Substantially Equivalent | |
| K864855 | AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT | JLS | Substantially Equivalent | |
| K860253 | AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) | CHO | Substantially Equivalent | |
| K860252 | AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA | CDP | Substantially Equivalent | |
| K860251 | AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA | CEC | Substantially Equivalent | |
| K852675 | AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT | JHI | Substantially Equivalent | |
| K851361 | AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM | CGJ | Substantially Equivalent | |
| K851104 | AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT | CEP | Substantially Equivalent | |
| K845026 | AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE | JLS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- CGNAcid, Folic, Radioimmunoassay
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- LCPAssay, Glycosylated Hemoglobin
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- JHYColorimetric Method, Cpk Or Isoenzymes
- KGIDensitometer, Bone
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- KXTEnzyme Immunoassay, Digoxin
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- DBFFerritin, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- KHQRadioassay, Triiodothyronine Uptake
- CDDRadioassay, Vitamin B12
- CGRRadioimmunoassay, Cortisol
- CHORadioimmunoassay, Cyclic Amp
- LCSRadioimmunoassay, Digoxin (125-I)
- DLPRadioimmunoassay, Diphenylhydantoin
- CHPRadioimmunoassay, Estradiol
- CGIRadioimmunoassay, Estriol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- JMFRadioimmunoassay, Human Placental Lactogen
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- IXDSource, Calibration, Sealed, Nuclear
- IWASource, Wire, Iridium, Radioactive
- IWJSystem, Applicator, Radionuclide, Manual
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain