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510(k) K850052

Device
ANAEROBE KIT
Applicant
AUSTIN BIOLOGICAL LABORATORIES
510(k) number
K850052
Product code
JSP  
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-05
Date received
1985-01-08
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#

Contact
RAY SCHNEIDER
Address
6620-A Manor Rd. Austin TX US 78723 78723

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
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
K820483IDA RAPID O2A SYSTEMInnovative Diagnostic Systems, Inc.1982-03-15
K802626ANAIROBE-TEKFlow Laboratories, Inc.1980-11-12

Legacy Summary#

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FDA Review#

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