Atlas FDA

LDM

19 FDA 510(k) clearances · Product code

42 daysmedian time to decision
161 days90th percentile
19clearances measured

FDA profile

Official device name
Instrumentation, High Pressure Liquid Chromatography
Device class
Class I (low risk)
Regulation
21 CFR 862.2260
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2004: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CDM (K960392)Bio-Rad1996-07-08
ALLIANCE 2690 SEPARATIONS MODULE (K961557)Waters Corporation1996-07-05
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM (K942451)Bio-Rad1994-11-10
WATERS(TM) LC MODULE I FOR CLINICAL USE (K922388)Millipore Corp.1992-09-11
WATERS 717 AUTOSAMPLER (K920136)Millipore Corp.1992-02-19
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (K903647)Millipore Corp.1990-09-11
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP (K884886)The Perkin-Elmer Corp.1989-02-02
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM (K872582)Millipore Corp.1987-07-16
WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM (K870949)Millipore Corp.1987-04-22
ISOPURE LC SYSTEM (K862178)The Perkin-Elmer Corp.1986-07-14
WATERS 740 DATA MODULE-PLOTTER INTEGRATOR (K850272)Millipore Corp.1985-03-06
WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D (K850359)Millipore Corp.1985-03-05
REPORTING INTEGRATOR 3392A (K833113)Hewlett-Packard Co.1983-11-21
LIQUID CHROMATOGRAPH 1090 SERIES (K832375)Hewlett-Packard Co.1983-10-14
SERIES 10 LIQUID CHROMOTOGRAPH (K821727)The Perkin-Elmer Corp.1982-06-22
SERIES 4 LIQUID CHROMATOGRAPH (K821219)The Perkin-Elmer Corp.1982-05-28
MODEL LC-85 UV DETECTOR (K810304)The Perkin-Elmer Corp.1981-02-25
3390A REPORTING INTEGRATOR (K802031)Hewlett-Packard Co.1980-09-16
PREP I AUTOMATED SAMPLE PROCESSOR (K780933)E.I. Dupont DE Nemours & Co., Inc.1978-07-27

Track LDM automatically

Every clearance here is in the API, with alerts when new ones post.