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510(k) K890332

Device
RFA/2 RAPID FLOW ANALYZER W/COMPUTER
Applicant
ALPKEM CORP.
510(k) number
K890332
Product code
JJC  
Decision
Substantially Equivalent (SESE)
Decision date
1989-02-17
Date received
1989-01-23
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
Third party reviewed
No

Applicant Contact#

Contact
RAYMOND L PAVITT
Address
Box 1260 Clackamas OR US 97015 97015

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
K945584NOVA 16 ANALYZERNova Biomedical Corp.1995-02-08
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
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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