FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANDROSTENEDIONE BY RIA
K Number: K842960
·
Decision Sep 27, 1984
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
9
Applicant Total
15
Review Days
62
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Basic Information
- Device Name
- ANDROSTENEDIONE BY RIA
- K Number
- K842960
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1075
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Radioassay Systems Laboratories, Inc.
- Date Received
- July 27, 1984
- Decision Date
- September 27, 1984
- Product Code
- CIZ
- 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 |
|---|---|---|---|
| CIZ | Radioimmunoassay, Androstenedione | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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DSL ANDROSTENEDIONE RIA (DSL # 4200)
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DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
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·Clinical Chemistry
Other Clearances by Radioassay Systems Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862204 | RSL (125I) ALDOSTERONE KIT | Sep 25, 1986 | Substantially Equivalent |
| K840886 | HYDROXYPROGESTERONE BY RIA 17A | Apr 18, 1984 | Substantially Equivalent |
| K831855 | HATCH KIT | Jul 28, 1983 | Substantially Equivalent |
| K802195 | DEHYDROEPIANDROSTERONE SULFATE KIT RIA | Oct 23, 1980 | Substantially Equivalent |
| K800126 | RSL (125 L) PROGESTERONE KIT | Feb 13, 1980 | Substantially Equivalent |
| K791999 | (125I) TESTOSTERONE KIT | Oct 30, 1979 | Substantially Equivalent |
| K791651 | TOTAL ESTROGENS KIT BY RIA | Sep 27, 1979 | Substantially Equivalent |
| K791728 | RSL'S ASSAY PROCEDURE QUANTITATION | Sep 27, 1979 | Substantially Equivalent |
| K791740 | SERUM 11-DESOXYCORTISOL I AS TRACER | Sep 27, 1979 | Substantially Equivalent |
| K791835 | CORALENT COAT 125I CORTISOL RADIOIMM. | Sep 27, 1979 | Substantially Equivalent |