FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
K Number: K884886
·
Decision Feb 2, 1989
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
18
Applicant Total
62
Review Days
72
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Basic Information
- Device Name
- MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
- K Number
- K884886
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- The Perkin-Elmer Corp.
- Date Received
- November 22, 1988
- Decision Date
- February 2, 1989
- Product Code
- LDM
- 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 |
|---|---|---|---|
| LDM | Instrumentation, 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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| K871550 | PFI-20 POLARIZING FLUORIMETER | Jul 1, 1987 | Substantially Equivalent |
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| K870661 | LIFEWATCH PLUS | Mar 9, 1987 | Substantially Equivalent |
| K862605 | MODULAR MASS SPECTROMETER (M.S.) | Aug 13, 1986 | Substantially Equivalent |
| K862178 | ISOPURE LC SYSTEM | Jul 14, 1986 | Substantially Equivalent |