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FDA 510(k)

MICROSTREP PLUS PANEL, AZITHROMYCIN

K-Number: K021169 · 2002-06-06

ApplicantDade Microscan, Inc.
Decision Date2002-06-06
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSTREP PLUS PANEL, AZITHROMYCIN 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 2002-06-06 under 510(k) number K021169. 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 MICROSTREP PLUS PANEL, AZITHROMYCIN?

MICROSTREP PLUS PANEL, AZITHROMYCIN is a medical device that received FDA 510(k) clearance on 2002-06-06. The listed applicant is Dade Microscan, Inc.. The 510(k) number is K021169.

When did MICROSTREP PLUS PANEL, AZITHROMYCIN receive FDA 510(k) clearance?

MICROSTREP PLUS PANEL, AZITHROMYCIN received FDA 510(k) clearance on 2002-06-06, under 510(k) number K021169.

Who is the listed applicant for MICROSTREP PLUS PANEL, AZITHROMYCIN?

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 MICROSTREP PLUS PANEL, AZITHROMYCIN?

The FDA product code for MICROSTREP PLUS PANEL, AZITHROMYCIN is JWY.

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Official Source

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