FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
K Number: K123955
·
Decision Mar 8, 2013
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
13
Applicant Total
7
Review Days
77
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Basic Information
- Device Name
- QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
- K Number
- K123955
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Life Technologies Corporation
- Date Received
- December 21, 2012
- Decision Date
- March 8, 2013
- Product Code
- OOI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| OOI | Real Time Nucleic Acid Amplification System | FDA class 2 | Clinical Chemistry |
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