FDA 510(k)

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

K-Number: K983408 · 1999-05-10

Decision Date1999-05-10

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS 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 1999-05-10 under 510(k) number K983408. 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 DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS?

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS is a medical device that received FDA 510(k) clearance on 1999-05-10. The listed applicant is Dade Microscan, Inc.. The 510(k) number is K983408.

When did DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS receive FDA 510(k) clearance?

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS received FDA 510(k) clearance on 1999-05-10, under 510(k) number K983408.

Who is the listed applicant for DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS?

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 DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS?

The FDA product code for DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS 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.