Atlas FDA

JJS

67 FDA 510(k) clearances · Product code

35 daysmedian time to decision
100 days90th percentile
67clearances measured

FDA profile

Official device name
Controls For Blood-Gases, (Assayed And Unassayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Medical specialty
Clinical Chemistry
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RecordFirmDate
CueSee Hypoxic (K152553)Eurotrol B.V.2016-04-22
Hematocrit and Metabolite QUALICHECK (K150226)Radiometer Medical Aps2015-05-13
HIGH METABOLITE QUALICHECK (K130415)Radiometer Medical Aps2013-03-26
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 (K130236)Radiometer Medical Aps2013-03-15
MISSION CONTROLS (K033063)Diamond Diagnostics, Inc.2003-12-12
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 (K022529)Bio-Rad2002-08-15
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 (K022525)Bio-Rad2002-08-15
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (K003242)Bio-Rad2000-11-30
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (K003239)Bio-Rad2000-11-30
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (K002865)Bio-Rad2000-09-25
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 (K002866)Bio-Rad2000-09-25
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) (K002536)Bio-Rad2000-08-30
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 (K002535)Bio-Rad2000-08-30
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 (K002120)Bio-Rad2000-08-21
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 (K980135)Radiometer America, Inc.1998-01-28
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) (K972861)Instrumentation Laboratory CO1997-08-19
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) (K961354)Radiometer America, Inc.1996-06-14
MULTICHECK (K961355)Radiometer America, Inc.1996-06-14
TONOMETERED SLAINE BLOOD GAS CONTROL (K961441)Instrumentarium Corp.1996-04-30
EUROTROL GAS - ISE CONTROL (K955340)Direct Solutions1995-12-26
QUALICHECK 4 GLUCOSE (K952637)Radiometer America, Inc.1995-09-05
STAT PROFILE ULTRA BLOOD GAS CONTROLS (K952477)Nova Biomedical Corp.1995-07-06
ALKO TONOMETERED SALINE CONTROL (K950902)Alko Diagnostic Corp.1995-03-30
CERTAIN(R) ELITE LEVEL 1, 2 AND 3 (K946224)Ciba Corning Diagnostics Corp.1995-01-30
SPECTRUM CO-OXIMETER LINEARITY CONTROL (K945860)Phoenix Diagnostics, Inc.1995-01-17
MULTICHECK(TM) (K935515)Radiometer America, Inc.1994-04-26
MICROBACT SOLID PLATE SYSTEMS (K923342)Radiometer America, Inc.1992-09-22
BLOOD GAS/ISE LINEARITY CONTROL (K920285)Phoenix Diagnostics, Inc.1992-07-14
RNA MEDICAL'S EQUIL 55 (K922357)Bionostics, Inc.1992-06-30
QUALICHECK 4 (K915399)Radiometer America, Inc.1992-01-02
QUALICHECK 3 (K904733)Radiometer America, Inc.1990-11-02
BLOOD GAS CONTROLS (K901985)Phoenix Diagnostics, Inc.1990-06-06
BLOOD GAS/CO-OXIMETRY CONTROL (K901976)Phoenix Diagnostics, Inc.1990-05-31
CO-OXIMETER CONTROLS (K901986)Phoenix Diagnostics, Inc.1990-05-31
QUALICHECK 2 (K894110)Radiometer America, Inc.1989-08-03
MULTI-FUNCTION BLOOD GAS CONTROL (K874408)Bionostics, Inc.1987-12-14
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (K872196)American Dade1987-07-31
BAYER HEALTHCARE RAPIDQC PLUS (K870036)Ciba Corning Diagnostics Corp.1987-01-14
MARQUEST QC-IV TONOMETER (K855024)Marquest Medical Products, Inc.1986-04-07
MULTI FUNCTION BLOOD GAS CONTROL (K851911)Bionostics, Inc.1985-05-20
BLOOD GAS CONTROL, LEVEL I(ACIDOSIS (K841783)Bionostics, Inc.1984-06-14
AQUEOUS BLOOD GAS CONTROL (K833146)Bionostics, Inc.1983-11-28
AQUEOUS BLOOD GAS CONTROL LEVEL I,II & (K832003)American Dade1983-08-10
CERTAIN HB CO-OXIMETER CONTROL (K832028)Corning Medical & Scientific1983-07-18
REFEREE BLOOD GAS ANALYZER CONTROLS (K830181)Analytical Products, Inc.1983-02-28
CORNING CERTAIN TM (K820873)Corning Medical & Scientific1982-04-16
GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL (K820705)United Diagnostics, Inc.1982-04-01
FETAL-TEK CONTROL MATURE (K820319)Helena Laboratories1982-03-25
PATHWAY PH BLOOD GAS CONTROL (K820103)Beckman Instruments, Inc.1982-01-28
SQC BUFFER (K812601)Transidyne General Corp.1981-10-02
AQUEOUS BLOOD GAS CONTROLS (K812553)Fisher Scientific Co., LLC1981-09-23
PROTEIN-BASED BLOOD GAS CONTROL (K812541)American Dade1981-09-23
PH/BLOOD GAS CONTROL (ABC) (K811143)Instrumentation Laboratory CO1981-05-13
RESPA-TROL (K810107)Intensive Technology, Inc.1981-01-26
BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 (K801449)Health Diagnostics Corp.1980-07-21
REFEREE BFT BLOOD FOR TONOMETRY (K792447)Analytical Products, Inc.1979-12-27
GAS-TRAK BLOOD GAS CONTROL (K792098)United Diagnostics, Inc.1979-11-13
CORNING CONFIRM BLOOD GAS QUALITY CONTRO (K792180)Corning Medical & Scientific1979-11-13
FISHER DIAG. PRIME BLOOD GAS CONTROLS (K792143)Fisher Scientific Co., LLC1979-11-13
MEDICOR QUALITY CONTROL BUFFER (K791287)Medicor USA , Ltd.1979-08-16
MULTECON BLOOD GAS CONTROL (K790813)Ortho Diagnostics, Inc.1979-06-28
BIOSCAN E12 (K781421)Clinifax Industries, Ltd.1978-09-20
DYNEX BLOOD GAS QUALITY CONTROL SYS. (K780144)Analytical Products, Inc.1978-05-26
QUALICHECK TM (K771444)The London Co.1977-08-16
WHOLE BLOOD GAS CONTROL (K770950)Dade, Baxter Travenol Diagnostics, Inc.1977-08-02
TMA BICARBONATE DILUENT (K771044)Hyland Therapeutic Div., Travenol Laboratories1977-07-15
AQUEOUS PH/BLOOD GAS CONTROLS (K770228)Instrumentation Laboratory CO1977-06-27

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