FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
25-HYDROXYVITAMIN D 125I RIA KIT
K Number: K983617
·
Decision Nov 16, 1998
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
71
Review Days
32
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Basic Information
- Device Name
- 25-HYDROXYVITAMIN D 125I RIA KIT
- K Number
- K983617
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaSorin, Inc.
- Date Received
- October 15, 1998
- Decision Date
- November 16, 1998
- Product Code
- LCI
- 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 |
|---|---|---|---|
| LCI | Automated Radioimmunoassay Systems, For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCI), ordered by most recent decision date.
CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYSTEM 6000 AUTOMATED RIA ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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