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510(k) K771833

Device
CHOLESTEROL
Applicant
GAMMA ENTERPRISES, INC.
510(k) number
K771833
Product code
CGO  
Decision
Substantially Equivalent (SESE)
Decision date
1977-10-18
Date received
1977-09-21
Regulation
862.1175
Classification name
Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
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 CGO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K850938CHOLESTEROLDilab, Inc.1985-06-25
K811747KING DIAGNOSTICS CHOLESTEROL TESTKing Diagnostics, Inc.1981-07-10
K810090CHOLESTEROL REAGENTAnco Medical Reagents & Assoc.1981-01-26
K800682REAGENTS FOR DETERM. CHOLESTEROL/SERUMDiagnostic Solutions, Inc.1980-05-28
K781611CHOLESTEROL DET. IN SERUMFisher Scientific Co., LLC1978-10-24
K780545SR-PLUS DIRECT CHOLESTEROL TESTStanbio Laboratory1978-05-26
K772043ALPHA/CHOLStandard Scientific, Inc.1977-11-28
K771313CHOLESTEROL REAGENTMallinckrodt Critical Care1977-08-03
K771093UNIPAK CHOLESTEROLHarleco1977-07-21
K770457CHOLESTEROL PROCEDURE, TEKPOINT TOTALIcn Pharmaceuticals, Inc.1977-05-03

Legacy Summary#

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FDA Review#

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