FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANDROSTENEDIONE 125I KIT BY RIA
K Number: K860559
·
Decision Mar 14, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
9
Applicant Total
18
Review Days
28
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Basic Information
- Device Name
- ANDROSTENEDIONE 125I KIT BY RIA
- K Number
- K860559
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1075
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immuchem Corp.
- Date Received
- February 14, 1986
- Decision Date
- March 14, 1986
- 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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COAT-A-COUNT ANDROSTENEDIONE RIA KIT
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Other Clearances by Immuchem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883726 | THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL | Dec 15, 1988 | Substantially Equivalent |
| K871317 | FOLLICLE STIMULATING HORMONE (HFSH) | May 20, 1987 | Substantially Equivalent |
| K871542 | HPROLACTIN KIT | May 14, 1987 | Substantially Equivalent |
| K865071 | THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT | Mar 13, 1987 | Substantially Equivalent |
| K864144 | LUTEINIZING HORMONE (LH-IRMA) RIA KIT | Nov 24, 1986 | Substantially Equivalent |
| K854094 | IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS | Feb 28, 1986 | Substantially Equivalent |
| K830962 | IMMUCHEM COVALENT-COAT RIA KIT | May 4, 1983 | Substantially Equivalent |
| K822509 | COVALENT COAT RIA KIT | Sep 28, 1982 | Substantially Equivalent |
| K822140 | IMMUCHEM COVALENT-COAT | Aug 5, 1982 | Substantially Equivalent |
| K820329 | ESTRADIOL KIT BY RIA | Mar 4, 1982 | Substantially Equivalent |