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FDA 510(k)

GRAM NEGATIVE IDENTIFICATION PLUS CARD

K-Number: K962609 · 1996-08-30

ApplicantBiomerieux Vitek, Inc.
Decision Date1996-08-30
Product CodeLRH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GRAM NEGATIVE IDENTIFICATION PLUS CARD is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1996-08-30 under 510(k) number K962609. The device is classified under product code LRH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM NEGATIVE IDENTIFICATION PLUS CARD?

GRAM NEGATIVE IDENTIFICATION PLUS CARD is a medical device that received FDA 510(k) clearance on 1996-08-30. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K962609.

When did GRAM NEGATIVE IDENTIFICATION PLUS CARD receive FDA 510(k) clearance?

GRAM NEGATIVE IDENTIFICATION PLUS CARD received FDA 510(k) clearance on 1996-08-30, under 510(k) number K962609.

Who is the listed applicant for GRAM NEGATIVE IDENTIFICATION PLUS CARD?

The FDA 510(k) record lists Biomerieux Vitek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRAM NEGATIVE IDENTIFICATION PLUS CARD?

The FDA product code for GRAM NEGATIVE IDENTIFICATION PLUS CARD is LRH.

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Other records listing Biomerieux Vitek, Inc. as applicant

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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962549VIDAS CREATINE KINASE MB ASSAY 30-421

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Related Devices (Code: LRH)

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.

K961042MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANELDade Microscan, Inc.K926248READERAlamar Biosciences Laboratory, Inc.K920225AUTOSCEPTOR IDENTIFICATION SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic

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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