FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ION TRAP DETECTOR
K Number: K880090
·
Decision Mar 15, 1988
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
9
Applicant Total
4
Review Days
63
Basic Information
- Device Name
- ION TRAP DETECTOR
- K Number
- K880090
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2860
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- FINNIGAN CORP.
- Date Received
- January 12, 1988
- Decision Date
- March 15, 1988
- Product Code
- DOP
- 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 |
|---|---|---|---|
| DOP | Mass Spectrometer, Clinical Use | FDA class 1 | Clinical Chemistry |
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