FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIO IMMUNO ASSAY KIT/
K Number: K760619
·
Decision Dec 6, 1976
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
77
Applicant Total
18
Review Days
84
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Basic Information
- Device Name
- RADIO IMMUNO ASSAY KIT/
- K Number
- K760619
- 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
- September 13, 1976
- Decision Date
- December 6, 1976
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDD), ordered by most recent decision date.
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ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
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Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
FDA 510(k)
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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 |
| 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 |