FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INCOS 50 MASS SPECTROMETER
K Number: K880418
·
Decision May 31, 1988
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
9
Applicant Total
4
Review Days
120
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Basic Information
- Device Name
- INCOS 50 MASS SPECTROMETER
- K Number
- K880418
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2860
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Finnigan Corp.
- Date Received
- February 1, 1988
- Decision Date
- May 31, 1988
- Product Code
- DOP
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| DOP | Mass Spectrometer, Clinical Use | FDA class 1 | Clinical Chemistry |
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