FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMERLEX ESTRIOL RIA KIT
K Number: K810667
·
Decision Mar 31, 1981
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
94
Review Days
19
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Basic Information
- Device Name
- AMERLEX ESTRIOL RIA KIT
- K Number
- K810667
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Amersham Corp.
- Date Received
- March 12, 1981
- Decision Date
- March 31, 1981
- Product Code
- CGI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
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AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
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Other Clearances by Amersham Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K914135 | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 | Feb 18, 1992 | Substantially Equivalent |
| K912733 | AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT | Jul 22, 1991 | Substantially Equivalent |
| K912766 | AMERLITE CK-MB ASSAY | Jul 17, 1991 | Substantially Equivalent |
| K904666 | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 | Nov 2, 1990 | Substantially Equivalent |
| K902760 | AMERSHAM TSH CONTROL SERA | Jul 27, 1990 | Substantially Equivalent |
| K901854 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) | Jul 9, 1990 | Substantially Equivalent |
| K901857 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) | Jul 9, 1990 | Substantially Equivalent |
| K901848 | GADOLINIUM-153 BONE DENSITOMETER SOURCES | Jul 9, 1990 | Substantially Equivalent |
| K901832 | GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 | Jul 9, 1990 | Substantially Equivalent |
| K896270 | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 | Dec 12, 1989 | Substantially Equivalent |