FDA.reportPublic FDA data

510(k) K851928

Device
HEK GENCELLS
Applicant
GENUS DIAGNOSTICS
510(k) number
K851928
Product code
KIR  
Decision
Substantially Equivalent (SESE)
Decision date
1985-05-20
Date received
1985-05-02
Regulation
864.2280
Classification name
Cells, Animal And Human, Cultured
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PETER J MIONE
Address
225 Wildwood St. Woburn MA US 01801 01801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases