FDA 510(k)

MICROSTREP PLUS PANEL WITH AMPICILLIN

K-Number: K021037 · 2002-05-06

Decision Date2002-05-06

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MICROSTREP PLUS PANEL WITH AMPICILLIN is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2002-05-06 under 510(k) number K021037. 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 WITH AMPICILLIN?

MICROSTREP PLUS PANEL WITH AMPICILLIN is a medical device that received FDA 510(k) clearance on 2002-05-06. The listed applicant is Dade Behring, Inc.. The 510(k) number is K021037.

When did MICROSTREP PLUS PANEL WITH AMPICILLIN receive FDA 510(k) clearance?

MICROSTREP PLUS PANEL WITH AMPICILLIN received FDA 510(k) clearance on 2002-05-06, under 510(k) number K021037.

Who is the listed applicant for MICROSTREP PLUS PANEL WITH AMPICILLIN?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROSTREP PLUS PANEL WITH AMPICILLIN?

The FDA product code for MICROSTREP PLUS PANEL WITH AMPICILLIN 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.