Atlas FDA

JQW

140 FDA 510(k) clearances · Product code

48 daysmedian time to decision
117 days90th percentile
140clearances measured

FDA profile

Official device name
Station, Pipetting And Diluting, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2750
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2013: 11 · 2014: 11 · 2020: 27 · 2021: 30 · 2022: 44 · 2023: 36
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
BD VIPER INSTRUMENT (K023955)Becton, Dickinson & CO2003-06-24
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (K973335)Zenyx Scientific , Ltd.1998-04-30
2700 SAMPLE MANAGER (K980180)Waters Corporation1998-02-12
MASTERCAP AM 5.0/MASTERCAP RM 5.0 (K970420)Pharmacia, Inc.1997-06-30
MINI SAMPLER PROCESSOR (K970616)Cavro Scientific Instruments, Inc.1997-04-21
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (K962687)Nichols Institute Diagnostics1997-03-28
MINI SAMPLE PROCESSOR (K962859)Cavro Scientific Instruments, Inc.1996-10-29
MICROLAB 4000, MICROLAB 4200 (K961896)Hamilton Co.1996-08-16
IMPACT (K961694)Matrix Technologies Corp.1996-06-21
GENESIS (K953345)Tecan U.S., Inc.1995-11-21
MEDTEC AUTOBLOT 2000 (K951753)Medtec, Inc.1995-10-17
ROBOCAP (K952025)Pharmacia, Inc.1995-07-26
4 CHANNEL DISPENSER (K944556)Tecan U.S., Inc.1994-10-25
4 CHANNEL DISPENSER (K942655)Tecan U.S., Inc.1994-09-02
STAR I WORKSTATION (K942290)Standard Engineering1994-08-26
BIOMEK SL WITH BIOMEK SL INCUBATOR (K941498)Beckman Analytical and Biotechnology Development1994-07-14
STAT FAX 2600 (K941394)Awareness Technology, Inc.1994-06-03
IMPACT (K940390)Matrix Technologies Corp.1994-05-03
SYSTEM WASHER 100 (K936258)Eg&G Berthold1994-04-26
AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM (K934124)Andronic Devices, Ltd.1994-04-13
PLATO 3000 (K933088)Rosys, Inc.1994-02-25
MAXSOFTWARE (K925547)Diagnostic Products Corp.1993-01-26
ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE (K923879)Diagnostic Products Corp.1992-12-07
WELLWASH 4 MARK II (K922803)Denley Instruments, Inc.1992-11-05
DENLEY WELLPREP 2 SAMPLE PROCESSOR (K922327)Denley Instruments, Inc.1992-08-12
WELLPREP 2000 SAMPLE PROCESSOR (K922183)Denley Instruments, Inc.1992-08-11
AFFIRM PROCESSOR (K923268)Microprobe Corp.1992-07-30
AUTOLOADER (K921005)Innovative Medical Systems, Inc.1992-04-29
RSP MEGA SAMPLE PROCESSOR (K915492)Tecan U.S., Ltd.1992-02-21
STACKING MICROPLATE WASHER (K915284)Denley Instruments, Inc.1992-01-22
HY-PREP SYSTEM (K913809)Hyperion, Inc.1992-01-15
WELLPREP 1 (K913567)Denley Instruments, Inc.1991-10-04
ROSYS MODELS 100 AND 200 (K913664)Packard Instrument Co., Inc.1991-08-30
ROBOTIC SAMPLE PROCESSOR (K912036)Tecan U.S., Ltd.1991-07-26
MARK 5 ROBOTIC PIPETTOR (K912228)Diagnostic Products Corp.1991-06-06
STRATUS(R) AUTOMATED SAMPLE HANDLER (K911712)Baxter Healthcare Corp1991-05-15
ELECTRAPETTE (R) (K910140)Matrix Technologies Corp.1991-02-04
EPC ELECTRONIC PIPETTING SYSTEM (K902592)Ulster Scientific, Inc.1990-07-19
MICROPLATE REAGENT DISPENSER (K900599)Denley Instruments, Inc.1990-05-17
KEMBLE LIQUID HANDLING SYSTEM DISPENSER (K896684)Schiff & Co.1990-04-16
EXEC-WASH SOLID PHASE WASHING SYSTEM (K896631)Source Scientific Systems, Inc.1990-04-03
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM (K900775)Bio-Rad1990-03-09
ABBOTT COMMANDER PARALLEL PROCESSING CENTER (K897158)Abbott Laboratories1990-03-01
SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM (K893811)Sakura Finetek U.S.A., Inc.1989-09-07
DPC-ROBOSTAT(TM) (K894710)Diagnostic Products Corp.1989-08-31
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER (K894069)Abbott Laboratories1989-08-21
DENLEY WELLDILL 3 (K894272)Denley Instruments, Inc.1989-08-21
ROBOTIC SAMPLE PROCESSOR (K894126)Tecan U.S., Ltd.1989-08-15
DENLEY WELLWASH 2 AND 4 (K894271)Denley Instruments, Inc.1989-08-15
IMMUNO-WASH AUTOMATED TUBE WASHER (K893810)Ocean Scientific, Inc.1989-08-03
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM (K893775)E.I. Dupont DE Nemours & Co., Inc.1989-07-25
SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION) (K893400)Medical Robotics1989-06-23
DELTA (TM) ROBOTIC PIPETTOR (K893031)Diagnostic Products Corp.1989-06-21
HI CHEM WASH CONCENTRATE REAGENT #88805 (K890578)Hichem Diagnostics1989-03-10
AIR DISPLACEMENT PIPETTE (K885340)Ulster Scientific, Inc.1989-02-14
IDS-1600 SAMPLE HANDLING SYSTEM (K883470)Baxter Healthcare Corp1988-12-09
PROBE(TM) MODELS 700 AND 1000 (K883749)Packard Instrument Co., Inc.1988-11-10
DYNATECH SPD 2000, NUMBER 002-910-0000 (K881195)Dynatech Laboratories, Inc.1988-06-07
MULTI-ACCESS REAGENT DISPENSER (K873416)Electro-Nucleonics Laboratories, Inc.1987-10-09
DYNATECH SPD 3000, #002-900-0000 (K872363)Dynatech Laboratories, Inc.1987-07-16
TYTEM(R) REAGENT DISPENSER (K871687)Medical Laboratory Automation Systems, Inc.1987-05-20
BIOMEK 1000 AUTOMATED LABORATORY WORK STATION (K870544)Beckman Instruments, Inc.1987-04-22
SMI DIGITRON (K870406)American Dade1987-02-25
ELECTRA AUTOMATIC SAMPLER (K864875)Medical Laboratory Automation Systems, Inc.1987-02-13
SMI MULTIPETTOR(TM) (K863887)American Dade1986-11-05
ULTRAWASH I (K863623)Dynatech Laboratories, Inc.1986-10-21
ULTRAWASH II (K863624)Dynatech Laboratories, Inc.1986-10-21
SURESPOT (K862701)Helena Laboratories1986-08-19
PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM (K861580)Cetus Corp.1986-06-27
MODUMATIC (R) DILUTER (K861640)Tri-Continent Scientific, Inc.1986-05-23
POSID SAMPLER (K860508)Organon Teknika Corp.1986-05-02
TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 (K854406)Tecan U.S., Ltd.1986-02-10
DADE BLOOD GAS AMPUL INJECTOR (K852285)American Dade1985-07-09
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM (K851403)Ventrex Laboratories, Inc.1985-06-21
DROPSTIRS - PLASTIC DISPOSABLE PIPET (K850800)Berwick Medical Products, Inc.1985-04-02
EPPENDORF DILUTER (K844798)Medical Technomics, Ltd.1985-01-07
AUTOLOADER II (K843779)Electro-Nucleonics Laboratories, Inc.1985-01-03
FIAX 420 DILUTOR (K843621)Intl. Diagnostic Technology1984-09-28
PRECISION DISPENSER (K843606)Medical Technomics, Ltd.1984-09-21
LABOPETTOR (K843607)Medical Technomics, Ltd.1984-09-21
KEMBLE 405 (K842894)Kemble Instruments, Inc.1984-08-27
FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP (K843073)Greene International Corp.1984-08-24
SYVA IQ 190 DIGITAL PIPETTER DILUTER (K842390)Syva Co.1984-07-25
BEHRING ELISA PROCESSOR M (K841043)Behring Diagnostics, Inc.1984-07-06
HIGH SPEED DISPENSER (K840938)Micromedic Systems1984-04-19
ACCUFLEX (K834590)Micromedic Systems1984-03-19
MICROLAB M DILUTER/DISPENSER (K833959)Syva Co.1984-01-24
UR/RITE SYSTEM (K833666)Wright Laboratories, Inc.1984-01-13
IL MODEL 840 MICROPROCESSOR LOADER (K833505)Instrumentation Laboratory CO1984-01-11
ACCU-PREP PROGRAMMABLE AUTO-DILUTER (K832809)Beckman Instruments, Inc.1983-10-27
PB 600 REPEATING DISPENSER (K832202)Hamilton Co.1983-08-24
PRECISION LIQUID DISPENSER (K832205)Hamilton Co.1983-08-24
MICROLAB P (K832204)Hamilton Co.1983-08-24
PRO QUANTUM (K831249)Abbott Laboratories1983-07-28
QST TM SAMPLE PROCESSOR (K831273)Syva Co.1983-06-02
AUTO PREP (K830319)Pm America, Inc.1983-03-29
DIGIFLEX AUTOMATIC PIPETTE (K830157)Micromedic Systems1983-03-10
COUNT-10 SYSTEM FOR STAND. URINALYSIS (K823364)V-Tech, Inc.1982-12-15
DIGITAL DILUTER/DISPENSERS (K822688)Hamilton Co.1982-11-05
CAVRO IQ-190 SAMPLE PROCESSOR (K822208)Cavro Scientific Instruments, Inc.1982-08-27
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