FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
K Number: K912733
·
Decision Jul 22, 1991
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
94
Review Days
32
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Basic Information
- Device Name
- AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
- K Number
- K912733
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Amersham Corp.
- Date Received
- June 20, 1991
- Decision Date
- July 22, 1991
- Product Code
- CIG
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
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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 |
| 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 |
| K895872 | LAN.0800Q/2800Q | Oct 17, 1989 | Substantially Equivalent |