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FDA 510(k)

VERDICT BARBITURATES

K-Number: K963529 · 1996-10-30

ApplicantEditek, Inc.
Decision Date1996-10-30
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VERDICT BARBITURATES is the device name listed in this FDA 510(k) record. The listed applicant is Editek, Inc.. It received FDA 510(k) clearance on 1996-10-30 under 510(k) number K963529. 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 VERDICT BARBITURATES?

VERDICT BARBITURATES is a medical device that received FDA 510(k) clearance on 1996-10-30. The listed applicant is Editek, Inc.. The 510(k) number is K963529.

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

VERDICT BARBITURATES received FDA 510(k) clearance on 1996-10-30, under 510(k) number K963529.

Who is the listed applicant for VERDICT BARBITURATES?

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 BARBITURATES?

The FDA product code for VERDICT BARBITURATES is DIS.

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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 THCK943712VERDICT OPIATESK943710VERDICT COCAINEK943711EZ-SCREEN:PCP

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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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