FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHROMATOGRAPHY CLINICAL USE 75JQR
K Number: K914841
·
Decision Dec 10, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
24
Applicant Total
30
Review Days
46
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Basic Information
- Device Name
- CHROMATOGRAPHY CLINICAL USE 75JQR
- K Number
- K914841
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Millipore Corp.
- Date Received
- October 25, 1991
- Decision Date
- December 10, 1991
- 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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