Atlas FDA

JJF

57 FDA 510(k) clearances · Product code

48 daysmedian time to decision
211 days90th percentile
57clearances measured

FDA profile

Official device name
Analyzer, Chemistry, Micro, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2170
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2006: 5 · 2007: 10 · 2009: 3 · 2010: 21 · 2011: 19 · 2012: 8
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
ETI-MAX 3000 (K052794)DiaSorin, Inc.2006-03-31
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER (K040332)Arkray, Inc.2004-06-16
LIGHTCYCLER INSTRUMENT VERSION 1.2 (K033734)Roche Diagnostics Corp.2003-12-17
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (K013654)Precision Systems, Inc.2002-06-05
ROCHE COBAS TAQMAN ANALYZER (K012966)Roche Molecular Systems, Inc.2002-02-01
CARESIDE ANALYZER (K993634)Careside, Inc.1999-12-02
VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (K973628)Vital Scientific N.V.1998-03-13
CARESIDE ANALYZER (K980056)Exigent Diagnostics, Inc.1998-03-06
MAGO AUTOMATED EIA PROCESSOR (K973177)Diamedix Corp.1997-10-09
SYNERMED IR 200 CHEMISTRY ANALYZER (K971491)Synermed, Inc.1997-06-26
ROCHE COBAS AMPLICOR ANALYZER (K964506)Roche Molecular Systems, Inc.1997-05-21
WINMAX SOFTWARE SYSTEMS (K965103)Diagnostic Products Corp.1997-05-09
HCL - 200 BIOCHEMISTRY ANALYZER (K964409)Hcl Laboratory Systems, Inc.1997-01-22
BRIO AUTOMATIC SAMPLINC UNIT (K961209)Seac S.R.L.1996-12-24
WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS (K943978)Waters Chromatography Division1995-05-02
SYNCHRON CX3 DELTA (K942676)Beckman-Diagnostic Systems Group1994-11-02
SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA (K925093)Beckman Instruments, Inc.1993-11-16
SYVA EDMS (K912055)Syva Co.1991-06-10
SYVA(R) ETS(R) PLUS SYSTEM (K903357)Syva Co.1990-09-27
MODIFIED PK300 AUTOMATIC EIA ANALYZER (K893768)Olympus Corp.1989-08-15
RECONDITIONED ASTRA (TM) 8 (K883298)Associated Electro-Medical Services, Inc.1989-03-16
RECONDITIONED ASTRA(TM) 4 (K883350)Associated Electro-Medical Services, Inc.1989-03-16
RFA-300 RAPID FLOW ANALYZER W/COMPUTER (K883020)Alpkem Corp.1988-09-02
SERALYZER III BLOOD CHEMISTRY ANALYZER (K872120)Miles Laboratories, Inc.1987-10-28
(FPIA) ASSAY BUFFER (K871486)Windsor Laboratories, Inc.1987-05-08
SYVA ETS SYSTEM (K863245)Syva Co.1987-03-13
PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER (K870777)Kone Instruments, Inc.1987-03-13
OLYMPUS PK300 (K864834)Olympus Corp.1987-02-20
SYNCHRON CX3 (K864236)Beckman Instruments, Inc.1986-12-31
HYBRITECH IMMUNOCHEMISTRY ANALYZER (K852385)Hybritech, Inc.1985-07-12
CLINICAL CHEMISTRY ANALYTICAL SYSTEM (K851933)Allied Instrumentation Laboratory1985-06-10
RFA-300 RAPID FLOW ANALYZER W/COMPUTER (K851542)Alpkem Corp.1985-05-10
COBAS MIRA (K851172)Roche Diagnostic Systems, Inc.1985-05-02
TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN (K850999)Technicon Instruments Corp.1985-04-08
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS (K844586)Instrumentation Laboratory CO1984-12-11
PROGRESS SELECTIVE DHEMISTRY ANALYZ (K840200)Kone Instruments, Inc.1984-04-04
QCA CHEMISTRY ANALYZER (K833998)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-01-30
SHABAN 9865 IL#78637 JUNCTION BLOC (K833804)Shaban Mfg. Co.1984-01-13
NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM (K833154)Nova Biomedical Corp.1983-12-08
NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU (K833153)Nova Biomedical Corp.1983-11-25
COMPUR EASY TOUCH CHEMISTRY ANALYZER- (K831227)Worthington Diagnostic Systems1983-06-02
RAPID CHEM ANALYZER II (K830095)Macomb Chemical Co.1983-01-28
AMES/GILFORD OPTIMATE CLIN. CHEM & THER (K821583)Gilford Instrument Laboratories, Inc.1982-06-24
MICROLYTE (K820541)Kone Instruments, Inc.1982-05-24
POLI-MAK MODEL F-4 (FINAL (K820748)Pm America, Inc.1982-04-06
4150 ALPHA AMINO ACID ANALYZER (K820415)Lkb Instruments, Inc.1982-03-11
AMINO ACID ANALYSER SYSTEM (K803004)Lkb Instruments, Inc.1980-12-22
ELECTROLY TE CHEMISTRY ANALYZER (K802398)Instrumentation Laboratory CO1980-10-31
WASH SOLUTION KIT, #88102 (K802264)Hi Chem, Inc.1980-10-31
ASTRA PRINTER PAPER #88112-CHLORIDE SILV (K802392)Hi Chem, Inc.1980-10-23
REAGENT KIT, LANCER GLUCOSE (K790197)Sherwood Medical Industries1979-03-12
HYCEL M (K790335)Hycel, Inc.1979-02-27
BECKMAN ASTRA SYSTEM (K781442)Beckman Instruments, Inc.1978-10-03
MEPA-1 BLOOD ANALYZER (K781606)Medico Electronic, Inc.1978-10-03
STAC SYSTEM (K771821)Technicon Instruments Corp.1977-11-07
STAC SYSTEM-ADDI. ANALYTES (K771939)Technicon Instruments Corp.1977-11-03
KEM-O-MAT (K771513)Coulter Electronics, Inc.1977-08-22

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