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510(k) K800039

Device
LITHIUM DILUENT (1500 MM/E)
Applicant
GILFORD DIAGNOSTICS
510(k) number
K800039
Product code
JIH  
Decision
Substantially Equivalent (SESE)
Decision date
1980-01-21
Date received
1980-01-07
Regulation
862.3560
Classification name
Flame Photometry, Lithium
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JIH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050338MODIFICATION TO: INSTAREAD LITHIUM SYSTEMAkers Biosciences, Inc.2005-03-04
K031579INSTAREAD LITHIUM SYSTEMAkers Laboratories, Inc.2003-12-19
K011033DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132Dade Behring, Inc.2001-06-07
K934106KODAK EKTACHEM DTSC II SLIDES (LI)Eastman Kodak Company1994-04-25
K924488KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)Eastman Kodak Company1993-01-26
K921403MODEL 654 ANALYZERCiba Corning Diagnostics Corp.1992-07-30
K895465AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZEBaxter Healthcare Corp1989-12-27
K894328TDX(R) LITES(TM) LITHIUMAbbott Laboratories1989-11-13
K830636POTASSIUM DILUENTShaban Mfg. Co.1983-04-05
K771303FLAME PHOTOMETER MODEL 460Corning Medical & Scientific1977-08-22
K770824FLAME PHOTOMETER MOLEL 4600, KDAAmerican Monitor Corp.1977-07-15

Legacy Summary#

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FDA Review#

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