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510(k) K884706

Device
Chloride Test (cl) Item #65659
Applicant
EM DIAGNOSTIC SYSTEMS, INC.
510(k) number
K884706
Product code
CHJ
Decision
Substantially Equivalent (SESE)
Decision date
1989-01-11
Date received
1988-11-09
Regulation
862.1170
Classification name
Mercuric Thiocyanate, Colorimetry, Chloride
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANNA G BENTLEY
Address
480 Democrat Rd. Gibbstown NJ US 08027 08027

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K943006CHLORIDE QVETPrisma Systems1994-12-07
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