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510(k) K943006

Device
CHLORIDE QVET
Applicant
PRISMA SYSTEMS
510(k) number
K943006
Product code
CHJ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-07
Date received
1994-06-23
Regulation
862.1170
Classification name
Mercuric Thiocyanate, Colorimetry, Chloride
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LARRY J BEASLEY
Address
1721 Black River Blvd. Suite 200 Rome NY US 13440 13440

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CHJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K010670PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.2001-04-26
K945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERCatachem, Inc.1995-02-22
K934136OLYMPUS CHLORIDE REAGENT, MODIFICATIONOlympus Corp.1993-11-05
K932528OLYMPUS CHLORID REAGENT, MODIFIEDOlympus Corp.1993-09-17
K925338OLYMPUS CHLORIDE REAGENTOlympus Corp.1992-12-11
K922921KING DIAGNOSTICS CHLORIDE REAGENTKing Diagnostics, Inc.1992-10-05
K923610OLYMPUS CHLORIDE REAGENTOlympus Corp.1992-10-02
K923036URINE CHLORIDEHeraeus Kulzer, Inc.1992-09-09
K911297CHLORIDE REAGENTIntersect Systems, Inc.1991-04-16
K910133CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIEDOlympus Corp.1991-02-27
K901500CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA.Olympus Corp.1990-07-10
K892929TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTESTechnicon Instruments Corp.1989-07-20
K890015BIOTROL CHLORIDEBiotrol, USA, Inc.1989-02-17
K884601TECHNICON SYSTEMS RA-100/ASSIST CHLORIDETechnicon Instruments Corp.1989-01-27
K884706CHLORIDE TEST (CL) ITEM #65659Em Diagnostic Systems, Inc.1989-01-11

Legacy Summary#

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FDA Review#

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