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FDA 510(k)

LABONE COCAINE METABOLITE MICRO-PLATE EIA

K-Number: K040198 · 2004-03-05

ApplicantLabone, Inc.
Decision Date2004-03-05
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LABONE COCAINE METABOLITE MICRO-PLATE EIA is the device name listed in this FDA 510(k) record. The listed applicant is Labone, Inc.. It received FDA 510(k) clearance on 2004-03-05 under 510(k) number K040198. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABONE COCAINE METABOLITE MICRO-PLATE EIA?

LABONE COCAINE METABOLITE MICRO-PLATE EIA is a medical device that received FDA 510(k) clearance on 2004-03-05. The listed applicant is Labone, Inc.. The 510(k) number is K040198.

When did LABONE COCAINE METABOLITE MICRO-PLATE EIA receive FDA 510(k) clearance?

LABONE COCAINE METABOLITE MICRO-PLATE EIA received FDA 510(k) clearance on 2004-03-05, under 510(k) number K040198.

Who is the listed applicant for LABONE COCAINE METABOLITE MICRO-PLATE EIA?

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

What is the FDA product code for LABONE COCAINE METABOLITE MICRO-PLATE EIA?

The FDA product code for LABONE COCAINE METABOLITE MICRO-PLATE EIA is DIO.

Related Clinical Trials

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Other records listing Labone, 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.

K033601LABONE MICRO-PLATE COTININE EIA

Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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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