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FDA 510(k)

STREPTOCOCCUS MIC PANEL

K-Number: K963641 · 1996-12-18

ApplicantDade Microscan, Inc.
Decision Date1996-12-18
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREPTOCOCCUS MIC 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 1996-12-18 under 510(k) number K963641. 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 STREPTOCOCCUS MIC PANEL?

STREPTOCOCCUS MIC PANEL is a medical device that received FDA 510(k) clearance on 1996-12-18. The listed applicant is Dade Microscan, Inc.. The 510(k) number is K963641.

When did STREPTOCOCCUS MIC PANEL receive FDA 510(k) clearance?

STREPTOCOCCUS MIC PANEL received FDA 510(k) clearance on 1996-12-18, under 510(k) number K963641.

Who is the listed applicant for STREPTOCOCCUS MIC 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 STREPTOCOCCUS MIC PANEL?

The FDA product code for STREPTOCOCCUS MIC PANEL is JWY.

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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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