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510(k) K113007

Device
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
Applicant
BIONIME CORPORATION
510(k) number
K113007
Product code
JQP  
Decision
Substantially Equivalent (SESE)
Decision date
2012-02-27
Date received
2011-10-07
Regulation
862.2100
Classification name
Calculator/data Processing Module, For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Feng-Yu Lee
Address
27001 La Paz Rd. Suite 266b Mission Viejo CA US 92691 92691

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JQP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K983468FASTTAKE ADAPTER, MODEL # P/N 020-072-01Selfcare, Inc.1998-12-17
K964460THE ROBOLITEShai Syg Motion and Innovations, Ltd.1997-01-24
K953652PRENVAL IBase Ten Systems, Inc.1995-09-15
K934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)Dynatech Laboratories, Inc.1994-11-02
K923316EXPRESSO CARTRIDGEBio-Rad Laboratories, Inc.1993-02-23
K893838MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZERCiba Corning Diagnostics Corp.1989-08-31
K892060CYBERLAB HIGH VOLUME DRUG TESTING SYSTEMSyva Co.1989-08-10
K885292COBAS MFCRoche Diagnostic Systems, Inc.1989-03-22
K881194RIA-QUICKQuantitative Technologies, Inc.1988-06-01
K871853V-MARC 88A COMPUTERV.Marc, A Div. of Pictorial, Inc.1987-07-16
K871339KALLESTAD QM300 PROTEIN ANALYSIS SYSTEMKallestad Diag, A Div. of Erbamont, Inc.1987-05-15
K864557710 PLUSCiba Corning Diagnostics Corp.1987-02-25
K861844GLUCOFACTS DATA MANAGEMENT SYSTEMMiles Laboratories, Inc.1986-08-12
K861779GLUCOFACTS DATA PRINTERMiles Laboratories, Inc.1986-08-08
K861778CLINIFACTS 200 DATA MANAGEMENT SYSTEMMiles Laboratories, Inc.1986-07-02

Legacy Summary#

summary

FDA Review#

Decision Summary