FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIANEN, VITAMIN B12 ASSAY SYSTEM
K Number: K792175
·
Decision Nov 13, 1979
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
77
Applicant Total
18
Review Days
15
Basic Information
- Device Name
- RIANEN, VITAMIN B12 ASSAY SYSTEM
- K Number
- K792175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- NEW ENGLAND NUCLEAR
- Date Received
- October 29, 1979
- Decision Date
- November 13, 1979
- Product Code
- CDD
- 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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | FDA class 2 | 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 |
| K831345 | RIANEN PROLACTIN 125I KIT | Jun 8, 1983 | Substantially Equivalent |
| K801245 | ATOMLIGHT (LIQUID SCINTILLATION SOLUTION | Jun 20, 1980 | 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 |