FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LDC SPECTROMONITOR III
K Number: K800289
·
Decision Feb 26, 1980
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
24
Applicant Total
4
Review Days
15
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Basic Information
- Device Name
- LDC SPECTROMONITOR III
- K Number
- K800289
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Laboratory Data Control
- Date Received
- February 11, 1980
- Decision Date
- February 26, 1980
- Product Code
- KIE
- 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 |
|---|---|---|---|
| KIE | Apparatus, High Pressure Liquid Chromatography | FDA class 1 | Clinical Chemistry |
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