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510(k) K943891

Device
RD CULTURE CELL
Applicant
NEOGENEX
510(k) number
K943891
Product code
KIR  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-28
Date received
1994-08-09
Regulation
864.2280
Classification name
Cells, Animal And Human, Cultured
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM E RADANY
Address
12811 Eight Ave. W. Suite A-101 Everett WA US 98204 98204

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KIR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973214FRESH CELLS HFFDiagnostic Hybrids, Inc.1997-09-25
K973213FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.1997-09-25
K973212FRESH CELLS WI-38Diagnostic Hybrids, Inc.1997-09-25
K973211FRESH CELLS MV1LUDiagnostic Hybrids, Inc.1997-09-25
K973210FRESH CELLS NCI H292Diagnostic Hybrids, Inc.1997-09-25
K973209FRESH CELLS VERODiagnostic Hybrids, Inc.1997-09-25
K971508RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTUREBio-Whittaker, Inc., A Cambrex Co.1997-09-17
K972414FRESHCELLSDiagnostic Hybrids, Inc.1997-08-29
K965047MINK LUNG CELL CULTURENeogenex1997-02-04
K962782FRESHFROZEN CELLS, HEP-2Diagnostic Hybrids, Inc.1996-08-29
K962780FRESHCELLS, HEP-2Diagnostic Hybrids, Inc.1996-08-29
K962311FRESHFROZENCELLSDiagnostic Hybrids, Inc.1996-08-29
K962306FRESH CELLS MULTI-WELL & SHELL VIAL CULTURESDiagnostic Hybrids, Inc.1996-08-29
K955608MCCOY CELL CULTURESVai Diagnostics, Inc.1996-07-08
K960909H292 CELL CULTURENeogenex1996-05-30

Legacy Summary#

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FDA Review#

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