FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
K Number: K121608
·
Decision Feb 15, 2013
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
45
Applicant Total
106
Review Days
259
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Basic Information
- Device Name
- VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
- K Number
- K121608
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1825
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- June 1, 2012
- Decision Date
- February 15, 2013
- 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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