FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP
K Number: K935666
·
Decision Apr 26, 1994
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
24
Applicant Total
62
Review Days
151
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Basic Information
- Device Name
- PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP
- K Number
- K935666
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Perkin-Elmer Corp.
- Date Received
- November 26, 1993
- Decision Date
- April 26, 1994
- 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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Other Clearances by The Perkin-Elmer Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K872737 | PERKIN-ELMER LC235 DIODE ARRAY DETECTOR | Sep 18, 1987 | Substantially Equivalent |
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| K862605 | MODULAR MASS SPECTROMETER (M.S.) | Aug 13, 1986 | Substantially Equivalent |
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