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FDA 510(k)

MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN

K-Number: K993679 · 2000-01-14

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

Device Summary

MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN 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 K993679. 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 - HAEMOPHILUS/AMPICILLIN?

MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN 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 K993679.

When did MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN receive FDA 510(k) clearance?

MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN received FDA 510(k) clearance on 2000-01-14, under 510(k) number K993679.

Who is the listed applicant for MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN?

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 - HAEMOPHILUS/AMPICILLIN?

The FDA product code for MICROSTREP PLUS PANEL - HAEMOPHILUS/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.

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