FDA.reportPublic FDA data

510(k) K960392

Device
Cdm
Applicant
BIO-RAD
510(k) number
K960392
Product code
LDM
Decision
Substantially Equivalent (SESE)
Decision date
1996-07-08
Date received
1996-01-29
Regulation
862.2260
Classification name
Instrumentation, High Pressure Liquid Chromatography
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN W NELSON
Address
4000 Alfred Nobel Dr. Hercules CA US 94547 94547

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LDM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961557ALLIANCE 2690 SEPARATIONS MODULEWaters Corporation1996-07-05
K942451BIO-RAD CLINICAL DATA MANAGEMENT SYSTEMBio-Rad1994-11-10
K922388WATERS(TM) LC MODULE I FOR CLINICAL USEMillipore Corp.1992-09-11
K920136WATERS 717 AUTOSAMPLERMillipore Corp.1992-02-19
K903647MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETEMillipore Corp.1990-09-11
K884886MODEL 250 LIQUID CHROMOTAGRAPHY PUMPThe Perkin-Elmer Corp.1989-02-02
K872582HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEMMillipore Corp.1987-07-16
K870949WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEMMillipore Corp.1987-04-22
K862178ISOPURE LC SYSTEMThe Perkin-Elmer Corp.1986-07-14
K850272WATERS 740 DATA MODULE-PLOTTER INTEGRATORMillipore Corp.1985-03-06
K850359WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL DMillipore Corp.1985-03-05
K833113REPORTING INTEGRATOR 3392AHewlett-Packard Co.1983-11-21
K832375LIQUID CHROMATOGRAPH 1090 SERIESHewlett-Packard Co.1983-10-14
K821727SERIES 10 LIQUID CHROMOTOGRAPHThe Perkin-Elmer Corp.1982-06-22
K821219SERIES 4 LIQUID CHROMATOGRAPHThe Perkin-Elmer Corp.1982-05-28