Atlas FDA

JJQ

258 FDA 510(k) clearances · Product code

47 daysmedian time to decision
144 days90th percentile
258clearances measured

FDA profile

Official device name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2300
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2014: 69 · 2015: 13 · 2016: 9 · 2017: 10 · 2022: 22 · 2025: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (K013371)Otsuka Pharmaceutical Co., Ltd.2001-12-21
DIGENE DML 2000 MICROPLATE LUMINOMETER (K980120)Digene Corp.1998-02-06
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (K973938)Sfri, Inc.1998-02-04
STAT TRACKS (K974762)Awareness Technology, Inc.1998-01-28
ANTHOS PHACTS VERSION MICROPLATE READER (K962113)Columbia Bioscience, Inc.1996-11-05
CBI 7520 READER (K961183)Columbia Bioscience, Inc.1996-08-02
ORIGEN ANALYZER (K962166)Igen, Inc.1996-07-31
ANTHOS 2010 READER (K955077)Anthos Labtec, Inc.1995-12-04
ELX808 AUTOMATED MICROPLATE READERS (K953710)Bio-Tek Instruments, Inc.1995-10-25
ELX800UV (K953572)Bio-Tek Instruments, Inc.1995-10-19
BILI-METER (K953005)Olympic Medical Corp.1995-09-28
5STRATEC SL 300 LIA-MAT (K950029)Nichols Institute Diagnostics1995-08-02
DIGENE DCR-1 LUMINOMETER (K940486)Digene Diagnostics, Inc.1995-04-18
BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER (K942250)Biowhittaker Molecular Applications, Inc.1995-04-04
WHITSOFT (K942361)Biowhittaker Molecular Applications, Inc.1995-04-04
BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE (K942245)Biowhittaker Molecular Applications, Inc.1995-04-03
ELX800 AND EL800 AUTOMATED MICROPLATE READERS (K950104)Bio-Tek Instruments, Inc.1995-03-21
CERES 900C & CERES UV900C (K942923)Bio-Tek Instruments, Inc.1995-02-06
PLATO 3300/1300 (K943454)Rosys, Inc.1995-01-09
MICROREADER 4 (K935983)Hyperion, Inc.1994-12-09
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM (K943595)Instrumentation Laboratory CO1994-11-28
DUPONT ACA STAR (K941050)Dupont Medical Products1994-11-10
MRX MICROPLATE READER (K943701)Dynatech Laboratories, Inc.1994-10-20
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER (K932778)Boehringer Mannheim Corp.1993-11-17
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM (K932467)Instrumentation Laboratory CO1993-11-05
ACCULYTE CHEMILUMINESCENCE ANALYZER (K921536)Laboratory Technologies, Inc.1993-10-12
ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III (K931907)Anthos Labtec Instruments1993-09-29
OMNI (K925625)Bio-Tek Instruments, Inc.1993-08-19
OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER (K925935)Olympus Corp.1993-04-22
LYRIS 100/120 LABORATORY INFORMATION SYSTEM (K923844)Biovation, Inc.1992-12-11
TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 (K925203)Heraeus Kulzer, Inc.1992-11-25
LUMICO ANALYZER SA-300 (K923158)Maruzen Petrochemical Co., Ltd.1992-11-17
BERTHOLD LB 954 (K922329)Eg&G Berthold Analytical Instruments, Inc.1992-11-16
LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT (K922976)Eg&G Berthold Analytical Instruments, Inc.1992-11-16
MICROLITE MICROTITER PLATE LUMINOMETER ML3000 (K923456)Dynatech Laboratories, Inc.1992-10-13
LABOTECH AUTOMATED MICROTITER ANALYZER (K922081)Innovative Medical Systems, Inc.1992-09-02
COBAS CORE IMMUNOCHEMISTRY SYSTEM (K921180)Roche Diagnostic Systems, Inc.1992-07-28
MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI (K915896)Dynatech Laboratories, Inc.1992-05-04
SLT SPECTRA (K915689)Slt Labinstruments, Inc.1992-04-22
SLT 340 ATTC (K915690)Slt Labinstruments, Inc.1992-04-22
MP/S SINGLE WAVELENGTH MINI PHOTOMETER (K920914)Artel, Inc.1992-03-23
ENCORE (K915113)Heraeus Kulzer, Inc.1992-03-18
AMERLITE PROCESSING CENTER (K915680)Eastman Kodak Company1992-03-11
AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT (K914906)Bio-Tek Instruments, Inc.1991-11-27
MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER (K913590)Dynatech Laboratories, Inc.1991-10-25
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE (K914202)Baxter Diagnostics, Inc.1991-10-11
MICROTAK PLUS (K913840)Syva Co.1991-09-30
IMX SELECT ANALYZER (K912368)Abbott Laboratories1991-09-11
OPUS(R) PLUS ANALYZER (K913295)Pb Diagnostic Systems, Inc.1991-09-11
METROLAB MODEL 1500 (K910806)Laboratorio Rodriguez Corswant S.R.L.1991-08-30
MICROTRAK MANAGER (K912959)Syva Co.1991-07-26
CHEM-LINK DATA BASE MANAGER (K912413)Technicon Instruments Corp.1991-07-01
OBA(TM) READER (K911045)Adeza Biomedical1991-06-24
TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE (K911438)Bio-Tek Instruments, Inc.1991-05-23
DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER (K904783)Industrial Chemical Measurement1991-04-18
SLT MICROPLATE WASHER (K910740)Tecan U.S., Ltd.1991-03-27
ECLIPSE ICA ANALYZER (K910302)Biotope, Inc.1991-02-22
DYNATECH MR4000 MICROPLATE READER (K904567)Dynatech Corp.1991-01-28
GEN-PROBE LUMINOMETER-LEADER 450 (K905762)Gen-Probe, Inc.1991-01-23
IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER (K905215)Cirrus Diagnostics, Inc.1991-01-11
GEN-PROBE PAL LUMINOMETER (K903911)Gen-Probe, Inc.1990-10-04
GEN-PROBE LUMINOMETER-LEADER 50 (K903934)Gen-Probe, Inc.1990-09-27
EURAMARK 610 PHOTOMETER (K903164)Euro-American Marketing Group, Inc.1990-08-09
SPECTROPHOTOMETER (MICROASSAY PLATE READERS) (K902776)Slt Labinstruments, Inc.1990-07-31
BEHRING CHROMOTIMER (K901829)Behring Diagnostics, Inc.1990-07-24
QUICK CHEM II (K901695)Seradyn, Inc.1990-05-24
MPR-4A - MICRO-PLATE READER (K901965)Tosoh Corp.1990-05-10
E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE (K901542)Source Scientific Systems, Inc.1990-04-26
DU PONT VISTA(R) IMMUNOASSAY SYSTEM (K900245)E.I. Dupont DE Nemours & Co., Inc.1990-04-11
AUTOMATED EIA MICROPLATE READER MODELS EL340/340I (K901059)Bio-Tek Instruments, Inc.1990-04-09
AUTOMATED EIA MICROPLATE READER MODELS EL312/312I (K901027)Bio-Tek Instruments, Inc.1990-04-09
NOVAPATH MICROPLATE READER (K900776)Bio-Rad1990-04-03
STAT FAX(TM)-2100 (K900224)Awareness Technology, Inc.1990-03-01
AUTOREADER CALIBRATION TEST PLATE (K900579)Bio-Tek Instruments, Inc.1990-02-27
BIOTRACK IMMUNOCHEMISTRY MONITOR (K900372)Biotrack, Inc.1990-02-23
ALLERCOAT MICROPLATE SYSTEM (K900028)Kallestad Diag, A Div. of Erbamont, Inc.1990-01-22
ACC.U.DIAL (K894423)Exocell, Inc.1989-12-27
COBAS READY (K896007)Roche Diagnostic Systems, Inc.1989-12-19
MODIFIED MODEL 535(TM) LUMINOMETER (K896117)Los Alamos Diagnostics1989-11-30
LP 400 MICROPLATE READER (K894859)Kallestad Diag, A Div. of Erbamont, Inc.1989-10-31
FASTEC 901 AGGLUTINATION PATTERN READER (K895967)Schiff & Co.1989-10-30
MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER (K895313)Dynatech Laboratories, Inc.1989-10-17
BIOTRACK PDS MONITOR (K895102)Biotrack, Inc.1989-10-10
GEMTAB SYSTEM (K894503)Pharmacia Eni Diagnostics, Inc.1989-09-05
DYNATECH MR 5000, CATALOG #011-976-0600 (K894687)Dynatech Laboratories, Inc.1989-08-31
DENLEY ANTHOS 2001 READER (K894270)Denley Instruments, Inc.1989-08-21
QUIDEL REFLECTANCE ANALYZER (K893738)Quidel Corp.1989-08-11
GENETIC SYSTEMS MICROPLATE READER (K891767)Genetic Systems Corp.1989-07-25
MICROTRAK EIA AUTOREADER (K891270)Syva Co.1989-06-16
THERMOMAX MICROPLATE READER, MODIFICATION (K892063)Molecular Devices Corp.1989-05-11
CLS 962 MICROPLATE PHOTOMETER (K891869)Cambridge Life Sciences Plc.1989-05-09
EIA READER MODEL EL301 (K890854)Bio-Tek Instruments, Inc.1989-03-16
MICROLITE TUBE LUMINOMETER #011-902-0000 (K890502)Dynatech Laboratories, Inc.1989-02-27
MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000) (K884782)Dynatech Laboratories, Inc.1989-02-17
PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO (K884864)The Perkin-Elmer Corp.1989-02-10
AUTOMATED EIA READER MODEL EL311 (K884124)Bio-Tek Instruments, Inc.1989-01-03
BEHRING TURBITIMER (K883646)Behring Diagnostics, Inc.1988-10-31
NOVASPEC II SPECTROPHOTOMETER (K883435)Pharmacia, Inc.1988-10-13
EMAX PRECISION MICROPLATE READER (K883302)Molecular Devices Corp.1988-09-13
STAT FAX(TM) (K882938)Awareness Technology, Inc.1988-09-09
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