FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMULITE/IMMULITE 1000 TURBO INTACT PTH
K Number: K053533
·
Decision Feb 3, 2006
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
3
Review Days
46
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Basic Information
- Device Name
- IMMULITE/IMMULITE 1000 TURBO INTACT PTH
- K Number
- K053533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostic Products Corporation
- Date Received
- December 19, 2005
- Decision Date
- February 3, 2006
- 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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