FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERIES 4 LIQUID CHROMATOGRAPH
K Number: K821219
·
Decision May 28, 1982
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
18
Applicant Total
62
Review Days
31
Basic Information
- Device Name
- SERIES 4 LIQUID CHROMATOGRAPH
- K Number
- K821219
- 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
- April 27, 1982
- Decision Date
- May 28, 1982
- Product Code
- LDM
- 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 |
|---|---|---|---|
| LDM | Instrumentation, High Pressure Liquid Chromatography | FDA class 1 | Clinical Chemistry |
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| K Number | Device Name | ||
|---|---|---|---|
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| K872464 | ION TRAP DETECTOR (ITD) | Aug 11, 1987 | Substantially Equivalent |
| K871550 | PFI-20 POLARIZING FLUORIMETER | Jul 1, 1987 | Substantially Equivalent |
| K872122 | 8000 SERIES GAS CHROMATOGRAPHS | Jun 17, 1987 | Substantially Equivalent |
| K870661 | LIFEWATCH PLUS | Mar 9, 1987 | Substantially Equivalent |
| K862605 | MODULAR MASS SPECTROMETER (M.S.) | Aug 13, 1986 | Substantially Equivalent |