510(k) K961968

Device: BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number: K961968
Product code: LQL
Decision: Substantially Equivalent (SESE)
Decision date: 1997-02-04
Date received: 1996-05-20
Regulation: 866.2660
Classification name: Gram Positive Identification Panel
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: VIRGINIA C WEINKNECHT
Address: P.O. Box 243 Cockeysville MD US 21030 21030

FDA Registration Numbers#

3013718871
1950204
1119779
1924669
3009637528
8010096
3006440892
2919016
9615754
1530126
8021914

Source Documents#

Other 510(k) Records For Product Code LQL #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K972576	GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90	Accumed Intl., Inc.	1998-01-22
K961730	RAPID GRAM-POSITIVE ID SYSTEM	Becton Dickinson Microbiology Systems	1997-02-04
K952095	VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)	Biomerieux Vitek, Inc.	1996-03-12
K925916	VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD	Biomerieux Vitek, Inc.	1993-03-23
K910304	RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA	Vitek Systems, Inc.	1991-07-26
K910537	VISI-STREP	Kev Connecticut Diagnostics, Inc.	1991-04-12
K901559	MODIFICATION TO API UNISCEPT 20GP	Analytical Products, Inc.	1990-09-10
K891004	RAPIDEC STAPH	Dms Products, Inc.	1989-11-09
K874606	CATHRA GRAM POSITIVE SCREEN	Mct Medical, Inc.	1988-05-06
K863038	GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL	American Micro Scan	1986-09-30

Legacy Summary#

summary

FDA Review#

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