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510(k) K963005

Device
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
Applicant
NOVA BIOMEDICAL CORP.
510(k) number
K963005
Product code
JFL  
Decision
Substantially Equivalent (SESE)
Decision date
1996-08-23
Date received
1996-08-02
Regulation
862.1160
Classification name
Ph Rate Measurement, Carbon-dioxide
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL W MAC DONALD
Address
200 Prospect St. Walham MA US 02454 02454

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JFL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-07
K040975GENCHEM CO2 ACID REAGENTGenchem, Inc.2004-12-27
K014034MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)Beckman Coulter, Inc.2001-12-18
K963541SIGMA DIAGNOSTICS CO2 ACID REAGENTSigma Diagnostics, Inc.1996-10-24
K963538SIGMA DIAGNOSTICS CO2ALKALINE BUFFERSigma Diagnostics, Inc.1996-10-11
K963540SIGMA DIAGNOSTICS ELECTROLYTE BUFFERSigma Diagnostics, Inc.1996-09-27
K933696SIGMA ELECTROLYTE REFERENCE REAGENTSigma Chemical Co.1994-01-03
K933691SIGMA CO2 ALKALINE BUFFER REAGENTSigma Chemical Co.1993-12-17
K933692SIGMA CO2 ACID REAGENTSigma Chemical Co.1993-12-09
K933695SIGMA ELECTROLYTE BUFFERSigma Chemical Co.1993-10-22
K925552HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812Hichem Diagnostics1993-02-12
K925553HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813Hichem Diagnostics1993-02-12
K900185NIIC MODEL: DX901 ASPIRATION SYSTEMNiic U.S.A., Inc.1990-05-24
K897183SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMSBeckman Instruments, Inc.1990-03-30
K900420BICARBONATE REAGENTS PRODUCT #7713 & #7714American Research Products Co.1990-03-01

Legacy Summary#

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FDA Review#

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