FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
K Number: K160724
·
Decision Sep 7, 2016
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
122
Applicant Total
32
Review Days
175
Basic Information
- Device Name
- ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
- K Number
- K160724
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Date Received
- March 16, 2016
- Decision Date
- September 7, 2016
- Product Code
- CGS
- 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 |
|---|---|---|---|
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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