FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BICARBONATE CALIBRATOR
K Number: K141374
·
Decision Jun 30, 2014
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
7
Review Days
34
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Basic Information
- Device Name
- BICARBONATE CALIBRATOR
- K Number
- K141374
- 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
- June 30, 2014
- Product Code
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K161297 | Beta-2-Microglobulin | Jun 7, 2016 | Substantially Equivalent |
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| K141388 | SYSTEM CALIBRATER | Jul 11, 2014 | Substantially Equivalent |
| K131546 | AU BICARBONATE REAGENT | Oct 9, 2013 | Substantially Equivalent |