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FDA 510(k)

EZ-SCREEN:BARBITURATES

K-Number: K905057 · 1990-11-28

ApplicantEnvironmental Diagnostics, Inc.
Decision Date1990-11-28
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EZ-SCREEN:BARBITURATES 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 1990-11-28 under 510(k) number K905057. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-SCREEN:BARBITURATES?

EZ-SCREEN:BARBITURATES is a medical device that received FDA 510(k) clearance on 1990-11-28. The listed applicant is Environmental Diagnostics, Inc.. The 510(k) number is K905057.

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

EZ-SCREEN:BARBITURATES received FDA 510(k) clearance on 1990-11-28, under 510(k) number K905057.

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

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:BARBITURATES?

The FDA product code for EZ-SCREEN:BARBITURATES is DIS.

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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: AMPHETAMINESK902681EZ-SCREEN:HCGK900203EZ-SCREEN:OPIATESK883105EZ-SCREEN CANNABINOID/COCAINEK862916EZ-SCREEN: CANNABINOID

Related Devices (Code: DIS)

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.

K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.K070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCPhamatech, Inc.K070009AT HOME DRUG TEST MODELS, 9308T AND 9308XPhamatech, Inc.K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics

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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