Atlas FDA

JTC

66 FDA 510(k) clearances · Product code

29 daysmedian time to decision
70 days90th percentile
66clearances measured

FDA profile

Official device name
Device, Microtiter Diluting/Dispensing
Device class
Class I (low risk)
Regulation
21 CFR 866.2500
Medical specialty
Microbiology
Adverse events (MAUDE)
2009: 388 · 2010: 190 · 2011: 47 · 2019: 102 · 2022: 26 · 2023: 15
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
FILTERMATE UNIVERSAL HARVESTER (K924907)Packard Instrument Co., Inc.1992-12-01
MICROMATE 196 MODEL A961960 (K901808)Packard Instrument Co., Inc.1990-06-20
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (K894645)Dynatech Laboratories, Inc.1989-10-17
MULTI-PROBE HEAD PLUS (K892369)Hamilton Co.1989-06-02
GENETIC SYSTEMS MICROPLATE WASHER (K891768)Genetic Systems Corp.1989-05-01
GENETIC SYSTEMS MICROPLATE STRIP WASHER (K891766)Genetic Systems Corp.1989-05-01
GENETIC SYSTEMS PIPETTOR/DILUTOR (K891765)Genetic Systems Corp.1989-05-01
WASHER 500 MICROELISA SYSTEM (K884695)Organon Teknika Corp.1988-12-13
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (K884125)Bio-Tek Instruments, Inc.1988-12-02
DYNATECH MR 250 MANUAL MICROELISA READER (K874598)Dynatech Laboratories, Inc.1987-11-20
MICROPLATE AUTO-WASHER (MOTORIZED STAGE) (K873542)Genetic Systems Corp.1987-09-23
MICROLAB AT (K871945)Hamilton Co.1987-05-29
CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 (K863423)Plastic Injectors, Inc.1986-09-16
CODE-A-WELL SERIES 1-600, 1-625 (K863374)Plastic Injectors, Inc.1986-09-11
MULTI-CHANNEL MICROPIPETTES (K862802)Dynatech Laboratories, Inc.1986-08-01
TITERTEK MICROPLATE WASHER S-12 (K862066)Flow Laboratories, Inc.1986-06-05
POLYPET (K860617)Instrumed, Inc.1986-03-03
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER (K853920)Bio-Tek Instruments, Inc.1985-10-22
SPR 2 AUTODILUTER (K853380)Scientific Sales Intl., Inc.1985-09-12
MIC-CONCEPT INOCULUM SEED TRAY (K851019)Microtech Medical Systems, Inc.1985-03-29
MIC-CONCEPT INOCULATOR (K851020)Microtech Medical Systems, Inc.1985-03-29
TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA (K850908)Flow Laboratories, Inc.1985-03-25
BIO-TEK AUTOMATED MICROPLATE WASHER EL402 (K850249)Bio-Tek Instruments, Inc.1985-03-13
INTIWASH MANUAL MICROPLATE WASHER (K850371)Inti Corp.1985-03-11
SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES (K844891)Slt Labinstruments, Inc.1985-02-25
SLT 223 DISPENSER FOR MICROTITERPLATES (K844893)Slt Labinstruments, Inc.1985-02-25
TITERTEK DULUTER/DISPENSER 78-640-00 (K844568)Flow Laboratories, Inc.1985-01-30
BIO-STAT III PLATE WASHER (K844552)Whittaker Bioproducts, Inc.1985-01-30
TITERTEK MICROPLATE WASHER 120 (K844500)Flow Laboratories, Inc.1985-01-22
T.I.M.E. DISPENSER (K843272)Dynatech Laboratories, Inc.1984-09-14
CODE-A-WELL 350 MICROTITRATION STRIPS (K842848)Plastic Injectors, Inc.1984-09-07
API UNISCEPT PLUS 140 INOCULATOR (K831462)Analytical Products, Inc.1983-08-12
MULTI-TITER DISPENSER (K832203)Hamilton Co.1983-08-08
WASHER 6000 MICRO-C LISA SYSTEM (K831640)Organon Teknika Corp.1983-08-08
PIPETTE 12 CHANNEL (K831644)Organon Teknika Corp.1983-08-01
API UNISCEPT PLUS AUTOINOCULATOR (K831341)Analytical Products, Inc.1983-06-02
MUELLER HINTON W/50% SHEEP BLOOD (K830059)bioMerieux, Inc.1983-02-09
OCTAPETTES (K823137)Corning Costar Corp.1982-12-03
DISPOSABLE DISPENSE MANIFOLD (K823218)Dynatech Laboratories, Inc.1982-11-16
96 WELL DISPENSER (K821961)Skatron, Inc.1982-07-22
MICROPLATE WASHING DEVICE (K820992)Skatron, Inc.1982-05-03
MIC-2000 PLUS, 96 CHANNEL DISPENSER (K820821)Dynatech Corp.1982-04-14
IMMUNOASSAY PLATE (K812860)Skatron, Inc.1981-10-26
TITERTEK AUTODROP (K812818)Flow Laboratories, Inc.1981-10-23
REPLICA PLATER (K810719)Dynatech Corp.1981-04-01
AUTODILUTER III (K810659)Dynatech Corp.1981-03-31
SCEPTOR SYSTEM AUTOMATED MODEL 216 (K810229)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-02-09
ASSAY STRIPS (K803244)Corning Costar Corp.1981-02-02
SEROCLUSTER FLEXIBLE VINYL U & V PL. (K803243)Corning Costar Corp.1981-01-28
SEROCLUSTER EIA PLATES (K803242)Corning Costar Corp.1981-01-28
MIC-2000 INOCULUM TRAY LID (K810039)Dynatech Corp.1981-01-28
SRD III (K810022)Dynatech Corp.1981-01-26
MICROMEDIC REAGENT DISPENSER (K803252)Micromedic Systems1981-01-12
IMMULON REMOVAWELL STRIPS #011-010-6301 (K802857)Dynatech Corp.1980-12-11
HIPPURATE DISK (K801305)Remel Co.1980-07-21
DISPENSING SEROLOGICAL PIPET (K801437)Amt Corp.1980-07-14
DYNAWASHER II (K800989)Dynatech Laboratories, Inc.1980-06-02
SEROCLUSTER U AND V (K800240)Corning Costar Corp.1980-02-13
MIC-2000 INOCULATOR TEMPLATE (K790974)Dynatech Laboratories, Inc.1979-06-20
MIC-2000 QUAD INOCULUM TRAY (K790971)Dynatech Laboratories, Inc.1979-06-20
HISTO-OILER (K790956)Dynatech Laboratories, Inc.1979-06-15
HISTO-DISPENSER (K790957)Dynatech Laboratories, Inc.1979-06-15
INOCULATOR, MIC-2000 DISPOSABLE (K790076)Dynatech Laboratories, Inc.1979-02-01
WASHER SYSTEM, MICROELISA (K781802)Metrix Teknika, Inc.1978-12-20
MINIWASH (K781942)Dynatech Laboratories, Inc.1978-12-04
MODEL 203 DISPENSER (K761149)Beckman Instruments, Inc.1976-12-09

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