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FDA 510(k)

VERDICT COCAINE

K-Number: K943710 · 1994-11-17

ApplicantEditek, Inc.
Decision Date1994-11-17
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VERDICT COCAINE is the device name listed in this FDA 510(k) record. The listed applicant is Editek, Inc.. It received FDA 510(k) clearance on 1994-11-17 under 510(k) number K943710. 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 VERDICT COCAINE?

VERDICT COCAINE is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Editek, Inc.. The 510(k) number is K943710.

When did VERDICT COCAINE receive FDA 510(k) clearance?

VERDICT COCAINE received FDA 510(k) clearance on 1994-11-17, under 510(k) number K943710.

Who is the listed applicant for VERDICT COCAINE?

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

What is the FDA product code for VERDICT COCAINE?

The FDA product code for VERDICT COCAINE is DIO.

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Other records listing Editek, 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.

K963692VERDICT PCPK963233EZ-SCREEN PROFILEK963516VERDICT THCK963529VERDICT BARBITURATESK943712VERDICT OPIATESK943711EZ-SCREEN:PCP

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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