FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIANEN PROLACTIN 125I KIT
K Number: K831345
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
18
Review Days
44
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Basic Information
- Device Name
- RIANEN PROLACTIN 125I KIT
- K Number
- K831345
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- New England Nuclear
- Date Received
- April 25, 1983
- Decision Date
- June 8, 1983
- Product Code
- CFT
- 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | FDA class 1 | Clinical Chemistry |
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Other Clearances by New England Nuclear
| K Number | Device Name | ||
|---|---|---|---|
| K841478 | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY | Jun 14, 1984 | Substantially Equivalent |
| K840301 | RIANEN ESTRIOL RADIOIMMUNOASSAY KIT | Mar 30, 1984 | Substantially Equivalent |
| K834038 | RIANEN FOLLICLE STIMULATING HORMONE | Jan 30, 1984 | Substantially Equivalent |
| K833376 | RIANEN LUTEINIZING HORMONE RIA KIT | Dec 20, 1983 | Substantially Equivalent |
| K801245 | ATOMLIGHT (LIQUID SCINTILLATION SOLUTION | Jun 20, 1980 | Substantially Equivalent |
| K792175 | RIANEN, VITAMIN B12 ASSAY SYSTEM | Nov 13, 1979 | Substantially Equivalent |
| K790817 | RIA KIT, QUANTITATION OF PROSTATIC ACID | May 7, 1979 | Substantially Equivalent |
| K782110 | RIA KIT, RIANEN CORTISOL | Jan 26, 1979 | Substantially Equivalent |
| K781888 | ASSAY SYSTEM, FERRITIN I KIT | Jan 10, 1979 | Substantially Equivalent |
| K781495 | RIANEN ASSAY SYSTEM, 125I KIT | Sep 14, 1978 | Substantially Equivalent |