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FDA 510(k)

MICROSTREP PLUS PANEL, VANCOMYCIN

K-Number: K983953 · 2000-01-14

ApplicantDade Microscan, Inc.
Decision Date2000-01-14
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSTREP PLUS PANEL, VANCOMYCIN 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 2000-01-14 under 510(k) number K983953. 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, VANCOMYCIN?

MICROSTREP PLUS PANEL, VANCOMYCIN is a medical device that received FDA 510(k) clearance on 2000-01-14. The listed applicant is Dade Microscan, Inc.. The 510(k) number is K983953.

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

MICROSTREP PLUS PANEL, VANCOMYCIN received FDA 510(k) clearance on 2000-01-14, under 510(k) number K983953.

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

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, VANCOMYCIN?

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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