FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARATHYROID HORMONE RADIOIMMUNOASSAY KIT
K Number: K850254
·
Decision Apr 3, 1985
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
14
Review Days
71
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Basic Information
- Device Name
- PARATHYROID HORMONE RADIOIMMUNOASSAY KIT
- K Number
- K850254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cambridge Medical Technology
- Date Received
- January 22, 1985
- Decision Date
- April 3, 1985
- Product Code
- CEW
- 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 |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | FDA class 2 | Clinical Chemistry |
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| K862871 | RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL | Aug 19, 1986 | Substantially Equivalent |
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| K855169 | T3 UPTAKE RADIOIMMUNOASSAY KIT | Feb 6, 1986 | Substantially Equivalent |
| K843635 | MATCHED COMPONENT SET FOR RADIOIMMUNO- | Sep 28, 1984 | Substantially Equivalent |
| K841042 | MATCHED COMPONENT SET RADIOIMMUNOASSAY | Apr 19, 1984 | Substantially Equivalent |