510(k) K954923

Device: BACTEC FUNGAL MEDIUM
Applicant: BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
510(k) number: K954923
Product code: JTA
Decision: Substantially Equivalent (SESE)
Decision date: 1996-11-21
Date received: 1995-10-26
Regulation: 866.2560
Classification name: Monitor, Microbial Growth
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: DAVID R MERTZ
Address: 7loveton Cir. Sparks MD US 21152 21152

FDA Registration Numbers#

1119779
3006988008
2022807
3013496958
9610126
1917413
1024879
1047843
1950204

Source Documents#

Other 510(k) Records For Product Code JTA #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K910835	BACTEC NR-860	Bd Becton Dickinson Vacutainer Systems Preanalytic	1991-03-11
K865021	BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987-02-06
K853011	BACTEC NR-730 BACTERIAL DETECTION SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-07-30
K842874	RADIOMETRIC BLOOD CULTURE VIALS, AEROBE	American Micro Scan	1984-09-12
K842279	BECTEC NR-660 BACTERIAL DETECT SYS	Bd Becton Dickinson Vacutainer Systems Preanalytic	1984-07-20
K833917	BAC-T-SCREEN	Marion Laboratories, Inc.	1984-01-13
K834264	REVERSE-FLOW SYSTEM	Applied Polytechnology, Inc.	1984-01-13
K810042	BACTEC BACTERIAL DETECTION SYSTEM: #5	Bd Becton Dickinson Vacutainer Systems Preanalytic	1981-01-28
K792575	BACTEC BACTERIAL DETECTION SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1979-12-27
K790297	DETECTION SYSTEM, MS-2 ELECTROCHEMICAL	Abbott Laboratories	1979-04-26

Legacy Summary#

summary

FDA Review#

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