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FDA 510(k)

SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM

K-Number: K020689 · 2002-10-31

ApplicantMidi, Inc.
Decision Date2002-10-31
Product CodeNJO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Midi, Inc.. It received FDA 510(k) clearance on 2002-10-31 under 510(k) number K020689. The device is classified under product code NJO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM?

SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-10-31. The listed applicant is Midi, Inc.. The 510(k) number is K020689.

When did SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM receive FDA 510(k) clearance?

SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM received FDA 510(k) clearance on 2002-10-31, under 510(k) number K020689.

Who is the listed applicant for SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM?

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

What is the FDA product code for SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM?

The FDA product code for SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM is NJO.

Related Clinical Trials

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Other records listing Midi, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K052485SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF

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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