LDM — Instrumentation, High Pressure Liquid Chromatography Class I

FDA Device Classification

FDA product code LDM covers "Instrumentation, High Pressure Liquid Chromatography", a Class I medical device regulated under 21 CFR 862.2260. Submissions are reviewed by the Clinical Chemistry panel. At least 19 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LDM
Device Class
Class I
Regulation Number
862.2260
Submission Type
Review Panel
TX
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K960392bio-radCDMJuly 8, 1996
K961557waters corporationALLIANCE 2690 SEPARATIONS MODULEJuly 5, 1996
K942451bio-radBIO-RAD CLINICAL DATA MANAGEMENT SYSTEMNovember 10, 1994
K922388milliporeWATERS(TM) LC MODULE I FOR CLINICAL USESeptember 11, 1992
K920136milliporeWATERS 717 AUTOSAMPLERFebruary 19, 1992
K903647milliporeMODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETESeptember 11, 1990
K884886perkin-elmerMODEL 250 LIQUID CHROMOTAGRAPHY PUMPFebruary 2, 1989
K872582milliporeHIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEMJuly 16, 1987
K870949milliporeWATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEMApril 22, 1987
K862178perkin-elmerISOPURE LC SYSTEMJuly 14, 1986
K850272milliporeWATERS 740 DATA MODULE-PLOTTER INTEGRATORMarch 6, 1985
K850359milliporeWATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL DMarch 5, 1985
K833113hewlett-packardREPORTING INTEGRATOR 3392ANovember 21, 1983
K832375hewlett-packardLIQUID CHROMATOGRAPH 1090 SERIESOctober 14, 1983
K821727perkin-elmerSERIES 10 LIQUID CHROMOTOGRAPHJune 22, 1982
K821219perkin-elmerSERIES 4 LIQUID CHROMATOGRAPHMay 28, 1982
K810304perkin-elmerMODEL LC-85 UV DETECTORFebruary 25, 1981
K802031hewlett-packard3390A REPORTING INTEGRATORSeptember 16, 1980
K780933e.i. dupont de nemours and coPREP I AUTOMATED SAMPLE PROCESSORJuly 27, 1978