Atlas FDA

JFL

28 FDA 510(k) clearances · Product code

60 daysmedian time to decision
158 days90th percentile
28clearances measured

FDA profile

Official device name
Ph Rate Measurement, Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1160
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
i-STAT CHEM8+ cartridge with the i-STAT 1 System (K191298)Abbott Point of Care, Inc.2020-02-07
GENCHEM CO2 ACID REAGENT (K040975)Genchem, Inc.2004-12-27
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (K014034)Beckman Coulter, Inc.2001-12-18
SIGMA DIAGNOSTICS CO2 ACID REAGENT (K963541)Sigma Diagnostics, Inc.1996-10-24
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER (K963538)Sigma Diagnostics, Inc.1996-10-11
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER (K963540)Sigma Diagnostics, Inc.1996-09-27
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) (K963005)Nova Biomedical Corp.1996-08-23
SIGMA ELECTROLYTE REFERENCE REAGENT (K933696)Sigma Chemical Co.1994-01-03
SIGMA CO2 ALKALINE BUFFER REAGENT (K933691)Sigma Chemical Co.1993-12-17
SIGMA CO2 ACID REAGENT (K933692)Sigma Chemical Co.1993-12-09
SIGMA ELECTROLYTE BUFFER (K933695)Sigma Chemical Co.1993-10-22
HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 (K925553)Hichem Diagnostics1993-02-12
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 (K925552)Hichem Diagnostics1993-02-12
NIIC MODEL: DX901 ASPIRATION SYSTEM (K900185)Niic U.S.A., Inc.1990-05-24
SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS (K897183)Beckman Instruments, Inc.1990-03-30
BICARBONATE REAGENTS PRODUCT #7713 & #7714 (K900420)American Research Products Co.1990-03-01
CARBON DIOXIDE REAGENT KIT (K873129)A-Kem, Inc.1987-10-23
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL (K842656)Shaban Mfg. Co.1984-08-12
FERMCOTEST CO2 REAGNET (K822117)Fermco Biochemics, Inc.1982-09-30
LIQUIZYME CO2REAGENT SET (K820388)American Research Products Co.1982-03-08
ASTRA (K811381)Chem-Elec, Inc.1981-08-13
BAKER DIAG. ULTRARATE CO2 REAGENT KIT (K802035)J.T. Baker Chemical Co.1980-09-26
NSI CARBON DIOXIDE REAGENT KIT (K800586)Nobel Scientific Industries, Inc.1980-04-04
CARBON DIOXIDE CUP REAGENT & REF.RGT. (K800218)Fisher Scientific Co., LLC1980-02-26
NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE (K792254)Nova Biomedical Corp.1979-12-06
CO2 REFERENCE REAGENT (K791687)Hi Chem, Inc.1979-09-17
CO2 CUP REAGENT (K791686)Hi Chem, Inc.1979-09-17
STAT/LYTE ANALYZER (K771592)Technicon Instruments Corp.1977-10-18

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