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510(k) K913456

Device
Visi-neisseria
Applicant
KEV CONNECTICUT DIAGNOSTICS, INC.
510(k) number
K913456
Product code
JSX
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-11
Date received
1991-08-05
Regulation
866.2660
Classification name
Kit, Identification, Neisseria Gonorrhoeae
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MENASHI COHENFORD
Address
36c Beatrice Ave. Danielson CT US 06239 06239

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JSX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960759GONOPOX TEST KITMedtex Laboratories, Inc.1996-09-18
K923566NIZYME TEST KITRemel Co.1992-11-02
K880511XACT NEISSERIAAustin Biological Laboratories1988-08-25
K881501MODIFIED IDS RAPID NH SYSTEMInnovative Diagnostic Systems, Inc.1988-05-18
K870117NEISSERIA/BRANHAMELLA DIFFERENTIAL TESTPro-Lab, Inc.1987-03-20
K853544QUAD FERM +Analytical Products, Inc.1985-09-05
K852998NEISSERIA - KWIK PLUSMicro-Bio-Logics1985-07-23
K852582GONI-KITCulture Kits, Inc.1985-07-12
K833307PHADEBACK G.C. POSITIVE CONTROLSPharmacia, Inc.1983-12-27
K833180GONOCHEK-IIE-Y Laboratories, Inc.1983-11-14
K830364NEISSERIA IDENTIFICATION DISCSOxoid U.S.A., Inc.1983-03-08
K812048IDS RAPIDS NH SYSTEMSCarr-Scarborough Microbiologicals, Inc.1981-08-18
K811412NEISSERIA-KWIKWindsor Laboratories, Inc.1981-06-16
K782013GONO-CELLAbbott Laboratories1979-04-23
K781108MICROCULT-GC CULTURE TESTMiles Laboratories, Inc.1978-08-31