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FDA 510(k)

MECTEST

K-Number: K945207 · 1995-09-25

ApplicantMeco Industries
Decision Date1995-09-25
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MECTEST is the device name listed in this FDA 510(k) record. The listed applicant is Meco Industries. It received FDA 510(k) clearance on 1995-09-25 under 510(k) number K945207. 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 MECTEST?

MECTEST is a medical device that received FDA 510(k) clearance on 1995-09-25. The listed applicant is Meco Industries. The 510(k) number is K945207.

When did MECTEST receive FDA 510(k) clearance?

MECTEST received FDA 510(k) clearance on 1995-09-25, under 510(k) number K945207.

Who is the listed applicant for MECTEST?

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

What is the FDA product code for MECTEST?

The FDA product code for MECTEST is DIO.

Related Clinical Trials

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.

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Other records listing Meco Industries 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.

K973986MECTEST

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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