FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEM CALIBRATER
K Number: K141388
·
Decision Jul 11, 2014
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
7
Review Days
45
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Basic Information
- Device Name
- SYSTEM CALIBRATER
- K Number
- K141388
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter Ireland, Inc.
- Date Received
- May 27, 2014
- Decision Date
- July 11, 2014
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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| K141374 | BICARBONATE CALIBRATOR | Jun 30, 2014 | Substantially Equivalent |
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