FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
K Number: K141928
·
Decision Nov 25, 2014
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
93
Applicant Total
14
Review Days
132
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Basic Information
- Device Name
- COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
- K Number
- K141928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Operations (Rdo)
- Date Received
- July 16, 2014
- Decision Date
- November 25, 2014
- Product Code
- DKB
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DKB | Calibrators, Drug Mixture | FDA class 2 | Clinical Toxicology |
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