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FDA 510(k)

EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS

K-Number: K962519 · 1996-09-04

ApplicantBehring Diagnostics, Inc.
Decision Date1996-09-04
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-09-04 under 510(k) number K962519. The device is classified under product code LCD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS?

EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS is a medical device that received FDA 510(k) clearance on 1996-09-04. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K962519.

When did EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS receive FDA 510(k) clearance?

EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS received FDA 510(k) clearance on 1996-09-04, under 510(k) number K962519.

Who is the listed applicant for EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS?

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

What is the FDA product code for EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS?

The FDA product code for EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS is LCD.

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Related Devices (Code: LCD)

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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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