510(k) K821219
- Device
- SERIES 4 LIQUID CHROMATOGRAPH
- Applicant
- THE PERKIN-ELMER CORP.
- 510(k) number
- K821219
- Product code
- LDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-05-28
- Date received
- 1982-04-27
- Regulation
- 862.2260
- Classification name
- Instrumentation, High Pressure Liquid Chromatography
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2915274
- 1832816
- 3003540486
- 9611444
- 1218959
- 3043088937
- 3008147369
- 3043138885
- 3027645317
- 3006850222
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LDM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960392 | CDM | Bio-Rad | 1996-07-08 |
| K961557 | ALLIANCE 2690 SEPARATIONS MODULE | Waters Corporation | 1996-07-05 |
| K942451 | BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM | Bio-Rad | 1994-11-10 |
| K922388 | WATERS(TM) LC MODULE I FOR CLINICAL USE | Millipore Corp. | 1992-09-11 |
| K920136 | WATERS 717 AUTOSAMPLER | Millipore Corp. | 1992-02-19 |
| K903647 | MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE | Millipore Corp. | 1990-09-11 |
| K884886 | MODEL 250 LIQUID CHROMOTAGRAPHY PUMP | The Perkin-Elmer Corp. | 1989-02-02 |
| K872582 | HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM | Millipore Corp. | 1987-07-16 |
| K870949 | WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM | Millipore Corp. | 1987-04-22 |
| K862178 | ISOPURE LC SYSTEM | The Perkin-Elmer Corp. | 1986-07-14 |
| K850272 | WATERS 740 DATA MODULE-PLOTTER INTEGRATOR | Millipore Corp. | 1985-03-06 |
| K850359 | WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D | Millipore Corp. | 1985-03-05 |
| K833113 | REPORTING INTEGRATOR 3392A | Hewlett-Packard Co. | 1983-11-21 |
| K832375 | LIQUID CHROMATOGRAPH 1090 SERIES | Hewlett-Packard Co. | 1983-10-14 |
| K821727 | SERIES 10 LIQUID CHROMOTOGRAPH | The Perkin-Elmer Corp. | 1982-06-22 |
Legacy Summary#
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FDA Review#
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