FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
ABX PENTRA MICRO ALB CONTROL L/H
K Number: K133676
·
Decision Jul 11, 2014
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
17
Review Days
224
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Basic Information
- Device Name
- ABX PENTRA MICRO ALB CONTROL L/H
- K Number
- K133676
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HORIBA ABX SAS
- Date Received
- November 29, 2013
- Decision Date
- July 11, 2014
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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