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510(k) K831075

Device
BLOOD GAS & FLAME PHOTOMETER INSTRU-
Applicant
UNITED DIAGNOSTICS, INC.
510(k) number
K831075
Product code
CGC  
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-22
Date received
1983-04-04
Regulation
862.1325
Classification name
Radioimmunoassay, Gastrin
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 CGC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961276GASTRIN EIA MODEL 06B-555017Biosyn , Ltd.1996-05-30
K842079GASTRIN 34 HORMONE BY RADIOUMMUNOASSAYImmuno Nuclear Corp.1984-06-26
K841963GASTRIN RIASyncor Intl. Corp.1984-06-25
K833489DPC GASTRIN KITDiagnostic Products Corp.1984-01-30
K821175GASTRIN RADIOIMMUNOASSAY KIT (125-I)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-05-14
K812727GASTRIN 1-17 BY RADIOIMMUNOASSAY KITImmuno Nuclear Corp.1981-11-05
K812004GASTRIN RIA DIAGNOSTIC KITAbbott Laboratories1981-07-28
K810722GASTRIN RADIOIMMUNOASSAY TESTClinical Assays, Inc.1981-05-27
K771953GASTRIN RIA MODULEInter Science Institute1978-01-20

Legacy Summary#

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FDA Review#

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