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FDA 510(k)

EZ-SCREEN CANNABINOID/COCAINE

K-Number: K883105 · 1988-12-16

ApplicantEnvironmental Diagnostics, Inc.
Decision Date1988-12-16
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EZ-SCREEN CANNABINOID/COCAINE is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-12-16 under 510(k) number K883105. 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 EZ-SCREEN CANNABINOID/COCAINE?

EZ-SCREEN CANNABINOID/COCAINE is a medical device that received FDA 510(k) clearance on 1988-12-16. The listed applicant is Environmental Diagnostics, Inc.. The 510(k) number is K883105.

When did EZ-SCREEN CANNABINOID/COCAINE receive FDA 510(k) clearance?

EZ-SCREEN CANNABINOID/COCAINE received FDA 510(k) clearance on 1988-12-16, under 510(k) number K883105.

Who is the listed applicant for EZ-SCREEN CANNABINOID/COCAINE?

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

What is the FDA product code for EZ-SCREEN CANNABINOID/COCAINE?

The FDA product code for EZ-SCREEN CANNABINOID/COCAINE 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 Environmental Diagnostics, 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.

K905700EZ-SCREEN: AMPHETAMINESK905057EZ-SCREEN:BARBITURATESK902681EZ-SCREEN:HCGK900203EZ-SCREEN:OPIATESK862916EZ-SCREEN: CANNABINOID

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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