FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
K Number: K102432
·
Decision Jan 14, 2011
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
45
Applicant Total
41
Review Days
141
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Basic Information
- Device Name
- DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
- K Number
- K102432
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1825
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diazyme Laboratories
- Date Received
- August 26, 2010
- Decision Date
- January 14, 2011
- Product Code
- MRG
- 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 |
|---|---|---|---|
| MRG | System, Test, Vitamin D | FDA class 2 | Clinical Chemistry |
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