FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
K Number: K140554
·
Decision Dec 19, 2014
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
45
Applicant Total
23
Review Days
290
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Basic Information
- Device Name
- IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
- K Number
- K140554
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1825
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunodiagnostic Systems , Ltd.
- Date Received
- March 4, 2014
- Decision Date
- December 19, 2014
- 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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