FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
K Number: K092705
·
Decision May 28, 2010
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
13
Applicant Total
17
Review Days
267
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Basic Information
- Device Name
- ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
- K Number
- K092705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Molecular, Inc.
- Date Received
- September 3, 2009
- Decision Date
- May 28, 2010
- 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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