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510(k) K945584

Device
NOVA 16 ANALYZER
Applicant
NOVA BIOMEDICAL CORP.
510(k) number
K945584
Product code
JJC  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-08
Date received
1994-11-14
Regulation
862.2150
Classification name
Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL W MACDONALD
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 JJC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945915AVL OMNI ANALYZERAvl Scientific Corp.1995-04-05
K943376OPERA SYSTEMMiles, Inc.1994-09-14
K901410TECHNICON RA-2000(TM) SYSTEMTechnicon Instruments Corp.1990-07-17
K901141PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZXBaxter Healthcare Corp1990-04-09
K890332RFA/2 RAPID FLOW ANALYZER W/COMPUTERAlpkem Corp.1989-02-17
K881056AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030American Research Products Co.1988-11-15
K875105TECHNICON SMAC 3 SYSTEMTechnicon Instruments Corp.1988-02-16
K870998TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYSTechnicon Instruments Corp.1987-05-26
K862561TECHNICON RA-XT SYSTEM WITH ANALYTESTechnicon Instruments Corp.1986-10-20
K854345TECHNICON RA-500 SYSTEMTechnicon Instruments Corp.1985-11-26
K852306REPLACEMENT REAGENTS FOR SMAC II SYSTEMSMethodist Hospital of Memphis1985-08-02
K833157LANCER ANALYZER CUPSSherwood Medical Co.1983-12-08
K833023TECHNICON RA-1000 SYSTEMTechnicon Instruments Corp.1983-11-03
K823233SBA 300 CLINICAL CHEMISTRY ANALYZERGilford Instrument Laboratories, Inc.1982-11-29
K813077TECHNICON RA 1000 SYSTEMTechnicon Corp.1981-11-16

Legacy Summary#

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FDA Review#

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