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FDA 510(k)

BBLCRYSTAL GRAM-POSITIVE ID SYSTEM

K-Number: K961968 · 1997-02-04

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1997-02-04
Product CodeLQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BBLCRYSTAL GRAM-POSITIVE ID SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K961968. The device is classified under product code LQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BBLCRYSTAL GRAM-POSITIVE ID SYSTEM?

BBLCRYSTAL GRAM-POSITIVE ID SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K961968.

When did BBLCRYSTAL GRAM-POSITIVE ID SYSTEM receive FDA 510(k) clearance?

BBLCRYSTAL GRAM-POSITIVE ID SYSTEM received FDA 510(k) clearance on 1997-02-04, under 510(k) number K961968.

Who is the listed applicant for BBLCRYSTAL GRAM-POSITIVE ID SYSTEM?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BBLCRYSTAL GRAM-POSITIVE ID SYSTEM?

The FDA product code for BBLCRYSTAL GRAM-POSITIVE ID SYSTEM is LQL.

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Related Devices (Code: LQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972576GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90Accumed Intl., Inc.K961730RAPID GRAM-POSITIVE ID SYSTEMBecton Dickinson Microbiology SystemsK952095VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)Biomerieux Vitek, Inc.K925916VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARDBiomerieux Vitek, Inc.K910304RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIAVitek Systems, Inc.K910537VISI-STREPKev Connecticut Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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