FDA 510(k)

MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN

K-Number: K972688 · 1997-09-08

Decision Date1997-09-08

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN 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 1997-09-08 under 510(k) number K972688. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN?

MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN is a medical device that received FDA 510(k) clearance on 1997-09-08. The listed applicant is Dade Microscan, Inc.. The 510(k) number is K972688.

When did MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN receive FDA 510(k) clearance?

MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN received FDA 510(k) clearance on 1997-09-08, under 510(k) number K972688.

Who is the listed applicant for MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN?

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 DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN?

The FDA product code for MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN is JWY.

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Other records listing Dade Microscan, Inc. as applicant

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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.