FDA.reportPublic FDA data

510(k) K820483

Device
IDA RAPID O2A SYSTEM
Applicant
INNOVATIVE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K820483
Product code
JSP  
Decision
Substantially Equivalent (SESE)
Decision date
1982-03-15
Date received
1982-02-22
Regulation
866.2660
Classification name
Kit, Anaerobic Identification
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
3404 Oakcliff Rd. #C-1 Atlanta GA US 30340 30340

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JSP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945489LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.1995-05-11
K945488LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.1995-05-11
K945487LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.1995-05-11
K944528BBLCRYSTAL ANAEROBE ID SYSTEMBecton Dickinson Microbiology Systems1995-03-07
K910666VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATIONVitek Systems, Inc.1991-04-03
K900996VITEK ANAEROBE IDENTIFICATION CARDVitek Systems, Inc.1990-05-11
K881380B. FRAGTEXAmerican Biomedical Products, Inc.1988-10-06
K882960IDS RAPID ANA SYSTEMInnovative Diagnostic Systems, Inc.1988-08-12
K855235DIAGNOSTIC REAGENT PET-RPLAOxoid U.S.A., Inc.1986-11-04
K862332ANAEROBE RAPID CHROMOGENIC ID PANELAmerican Micro Scan1986-08-27
K850052ANAEROBE KITAustin Biological Laboratories1985-03-05
K843686AMS ANA CARDVitek Systems, Inc.1984-12-12
K831032API ANAIDENTAnalytical Products, Inc.1983-05-05
K830964ANAEROBE MIC/ID TEMPLATE, & TAXONOMYBd Becton Dickinson Vacutainer Systems Preanalytic1983-05-04
K802626ANAIROBE-TEKFlow Laboratories, Inc.1980-11-12

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