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510(k) K860823

Device
ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT
Applicant
CIS-US, INC.
510(k) number
K860823
Product code
CFT  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-19
Date received
1986-03-04
Regulation
862.1625
Classification name
Radioimmunoassay, Prolactin (lactogen)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL D GARRETT
Address
1983 Marcus Ave. Lake Success NY US 11042 11042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CFT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobind1997-06-24
K970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.1997-02-25
K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.1997-02-20
K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.1997-01-21
K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.1996-04-26
K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, Inc.1996-02-29
K954680ACCESS PROLACTIN ASSAY (MODIFICATION)Bio-Rad Laboratories, Inc.1995-10-20
K953656ABBOTT IMX PROLACTIN(MODIFICATION)Abbott Mfg., Inc.1995-10-03
K953657ABBOTT AXSYM PROLACTIN(MODIFICATION)Abbott Mfg., Inc.1995-09-25
K944698AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1Organon Teknika Corp.1995-03-21
K943811ENZYME-LINKED FLUORESCENT IMMUNOASSAYBiomerieux Vitek, Inc.1994-11-02
K935675AXSYM PROLACTINAbbott Laboratories1994-06-21
K941220DUPONT ACA PLUS PROLACTIN (PROL) METHODDupont Medical Products1994-06-03
K941175ACCESS PROLACTINBio-Rad Laboratories, Inc.1994-06-02
K930305COBAS CORE PROLACTIN EIARoche Diagnostic Systems, Inc.1993-08-19

Legacy Summary#

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FDA Review#

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