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FDA 510(k)

MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL

K-Number: K961042 · 1996-05-30

ApplicantDade Microscan, Inc.
Decision Date1996-05-30
Product CodeLRH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Dade Microscan, Inc.. It received FDA 510(k) clearance on 1996-05-30 under 510(k) number K961042. 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 MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL?

MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL is a medical device that received FDA 510(k) clearance on 1996-05-30. The listed applicant is Dade Microscan, Inc.. The 510(k) number is K961042.

When did MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL receive FDA 510(k) clearance?

MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL received FDA 510(k) clearance on 1996-05-30, under 510(k) number K961042.

Who is the listed applicant for MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL?

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

What is the FDA product code for MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL?

The FDA product code for MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL is LRH.

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Other records listing Dade Microscan, Inc. as applicant

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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.

K962609GRAM NEGATIVE IDENTIFICATION PLUS CARDBiomerieux Vitek, 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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