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510(k) K853011

Device
Bactec Nr-730 Bacterial Detection System
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K853011
Product code
JTA
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-30
Date received
1985-07-16
Regulation
866.2560
Classification name
Monitor, Microbial Growth
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
J ARNSBERGER
Address
Mack Centre Dr. P.O.Box 2224 Paramus NJ US 07652 07652

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JTA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954923BACTEC FUNGAL MEDIUMBecton Dickinson Diagnostic Instrument Systems1996-11-21
K910835BACTEC NR-860Bd Becton Dickinson Vacutainer Systems Preanalytic1991-03-11
K865021BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1987-02-06
K842874RADIOMETRIC BLOOD CULTURE VIALS, AEROBEAmerican Micro Scan1984-09-12
K842279BECTEC NR-660 BACTERIAL DETECT SYSBd Becton Dickinson Vacutainer Systems Preanalytic1984-07-20
K833917BAC-T-SCREENMarion Laboratories, Inc.1984-01-13
K834264REVERSE-FLOW SYSTEMApplied Polytechnology, Inc.1984-01-13
K810042BACTEC BACTERIAL DETECTION SYSTEM: #5Bd Becton Dickinson Vacutainer Systems Preanalytic1981-01-28
K792575BACTEC BACTERIAL DETECTION SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1979-12-27
K790297DETECTION SYSTEM, MS-2 ELECTROCHEMICALAbbott Laboratories1979-04-26