FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHBG
K Number: K912850
·
Decision Aug 12, 1991
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
88
Applicant Total
13
Review Days
45
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Basic Information
- Device Name
- SHBG
- K Number
- K912850
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wien Laboratories, Inc.
- Date Received
- June 28, 1991
- Decision Date
- August 12, 1991
- 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 Wien Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834246 | PROGESTERONE TEST SET 125I 17-OH | Feb 4, 1984 | Substantially Equivalent |
| K832452 | ANDROSTENEDIONE TEST SET 125I | Sep 12, 1983 | Substantially Equivalent |
| K823200 | 125 I-DEHYDROEPIANDROSTERONE SULFATE | Nov 29, 1982 | Substantially Equivalent |
| K821653 | PROTRIPTYLINE TRI-CY TEST SET | Jun 14, 1982 | Substantially Equivalent |
| K821652 | DOXEPIN TRI-CY TEST SET | Jun 14, 1982 | Substantially Equivalent |
| K802728 | 125I-TESTOSTERONE TEST SET | Dec 11, 1980 | Substantially Equivalent |
| K792041 | DHEA-SULFATE TEST SET | Oct 30, 1979 | Substantially Equivalent |
| K781834 | TEST SET, 125 I-DIGOXIN | Jan 3, 1979 | Substantially Equivalent |
| K781599 | I-ESTRIOL TEST SET | Oct 17, 1978 | Substantially Equivalent |
| K772306 | 125I DIGOXIN TEST SET | Dec 22, 1977 | Substantially Equivalent |