FDA.reportPublic FDA data

510(k) K770398

Device
MINICON
Applicant
Amicon, Inc.
510(k) number
K770398
Product code
JJH
Decision
Substantially Equivalent (SESE)
Decision date
1977-04-06
Date received
1977-03-02
Regulation
862.2310
Classification name
Clinical Sample Concentrator
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K935496NANOSEP N10Intersep , Ltd.1994-04-26
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
K760592MINICON CONCENTRATORAmicon, Inc.1976-11-23