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510(k) K935496

Device
NANOSEP N10
Applicant
INTERSEP LTD.
510(k) number
K935496
Product code
JJH  
Decision
Substantially Equivalent (SESE)
Decision date
1994-04-26
Date received
1993-11-15
Regulation
862.2310
Classification name
Clinical Sample Concentrator
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD HICKS
Address
Crane House, Molly Millars Ln. Berkshire Rg11 2rz, England GB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JJH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K113731ESENSOR RESPIRATORY VIRAL PANELClinical Micro Sensors, Inc.2012-09-10
K960298VIVASPIN 4 10,000 MWVivascience, Inc.1996-03-19
K943965VIVAPORE 10Vivascience, Inc.1995-04-11
K943966VIVAPORE 2Vivascience, Inc.1995-04-11
K941326ULTRAFREE-CLMillipore Corp.1994-05-27
K930168CENTRICON -50 CONCENTRATORAmicon, Inc.1993-08-05
K893733CENTRICON CONCENTRATORAmicon, Inc.1989-07-20
K871290CENTRICELL(TM)Polysciences, Inc.1987-08-05
K870690CENTRIPREP CONCENTRATORAmicon, Inc.1987-03-19
K851393DUPONT PREP FOUR-SOLVENT RETROFIT KITE.I. Dupont DE Nemours & Co., Inc.1985-07-12
K833919CENTRICON MICRO-CONCENTRATORAmicon, Inc.1984-01-30
K801772MICROBIOLOGY CULTURE MEDIA-MACCONKEY AGRadiation Technology, Inc.1980-08-20
K770398MINICONAmicon, Inc.1977-04-06
K760592MINICON CONCENTRATORAmicon, Inc.1976-11-23

Legacy Summary#

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FDA Review#

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