FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
K Number: K120936
·
Decision Dec 13, 2012
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
93
Applicant Total
21
Review Days
260
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Basic Information
- Device Name
- ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
- K Number
- K120936
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microgenics Corporation
- Date Received
- March 28, 2012
- Decision Date
- December 13, 2012
- Product Code
- DKB
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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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