FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
(125I) TESTOSTERONE KIT
K Number: K791999
·
Decision Oct 30, 1979
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
88
Applicant Total
15
Review Days
25
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Basic Information
- Device Name
- (125I) TESTOSTERONE KIT
- K Number
- K791999
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Radioassay Systems Laboratories, Inc.
- Date Received
- October 5, 1979
- Decision Date
- October 30, 1979
- Product Code
- CDZ
- 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Radioassay Systems Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862204 | RSL (125I) ALDOSTERONE KIT | Sep 25, 1986 | Substantially Equivalent |
| K842960 | ANDROSTENEDIONE BY RIA | Sep 27, 1984 | 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 |
| 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 |