FDA.reportPublic FDA data

510(k) K970100

Device
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
Applicant
SIMPLICITY DIAGNOSTICS, INC.
510(k) number
K970100
Product code
MJX  
Decision
Substantially Equivalent (SESE)
Decision date
1997-03-10
Date received
1997-01-10
Regulation
862.1660
Classification name
Kit, Serological, Positive Control
Medical specialty
Clinical Chemistry
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY FLEISHMAN
Address
31 N. York Rd. Hatboro PA US 19040 19040

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MJX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K101434AUDIT MICROCV PROCALCITONIN LINEARITYAalto Scientific, Ltd.2010-07-22
K030067VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLSOrtho-Clinical Diagnostics2003-01-17
K974262SYSCOS IDC - G, IDC, BSC, IDC - GScantibodies Laboratory, Inc.1997-12-24
K972986ACCURUN 140 RUBELLA IGG POSITIVE CONTROLBoston Biomedica, Inc.1997-10-08
K934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONPb Diagnostic Systems, Inc.1994-03-07
K925703OPUS SEROLOGY CONTROLSPb Diagnostics, Inc.1993-04-08

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