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FDA 510(k)

EZ-SCREEN:OPIATES

K-Number: K900203 · 1990-03-09

ApplicantEnvironmental Diagnostics, Inc.
Decision Date1990-03-09
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EZ-SCREEN:OPIATES 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 1990-03-09 under 510(k) number K900203. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-SCREEN:OPIATES?

EZ-SCREEN:OPIATES is a medical device that received FDA 510(k) clearance on 1990-03-09. The listed applicant is Environmental Diagnostics, Inc.. The 510(k) number is K900203.

When did EZ-SCREEN:OPIATES receive FDA 510(k) clearance?

EZ-SCREEN:OPIATES received FDA 510(k) clearance on 1990-03-09, under 510(k) number K900203.

Who is the listed applicant for EZ-SCREEN:OPIATES?

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:OPIATES?

The FDA product code for EZ-SCREEN:OPIATES is DJG.

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:HCGK883105EZ-SCREEN CANNABINOID/COCAINEK862916EZ-SCREEN: CANNABINOID

Related Devices (Code: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

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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