FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANDROSTENEDIONE TEST SET 125I
K Number: K832452
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
9
Applicant Total
13
Review Days
49
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Basic Information
- Device Name
- ANDROSTENEDIONE TEST SET 125I
- K Number
- K832452
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1075
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Wien Laboratories, Inc.
- Date Received
- July 25, 1983
- Decision Date
- September 12, 1983
- 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
Other 510(k) clearances with the same product code (CIZ), ordered by most recent decision date.
ACTIVE ANDROSTENEDIONE EIA
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COAT-A-COUNT DIRECT ANDROSTENEDIONE
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ACTIVE ANDROSTANEDIOL GLUCURONIDE
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ANDROSTENEDIONE 125I KIT BY RIA
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DSL ANDROSTENEDIONE RIA (DSL # 4200)
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FDA Class 1
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DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Wien Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912850 | SHBG | Aug 12, 1991 | Substantially Equivalent |
| K834246 | PROGESTERONE TEST SET 125I 17-OH | Feb 4, 1984 | 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 |