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FDA 510(k)

BIONIKE AQ BARBITURATE TEST

K-Number: K990280 · 1999-06-28

ApplicantBionike, Inc.
Decision Date1999-06-28
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIONIKE AQ BARBITURATE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bionike, Inc.. It received FDA 510(k) clearance on 1999-06-28 under 510(k) number K990280. 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 BIONIKE AQ BARBITURATE TEST?

BIONIKE AQ BARBITURATE TEST is a medical device that received FDA 510(k) clearance on 1999-06-28. The listed applicant is Bionike, Inc.. The 510(k) number is K990280.

When did BIONIKE AQ BARBITURATE TEST receive FDA 510(k) clearance?

BIONIKE AQ BARBITURATE TEST received FDA 510(k) clearance on 1999-06-28, under 510(k) number K990280.

Who is the listed applicant for BIONIKE AQ BARBITURATE TEST?

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

What is the FDA product code for BIONIKE AQ BARBITURATE TEST?

The FDA product code for BIONIKE AQ BARBITURATE TEST is DIS.

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Other records listing Bionike, 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.

K970008ADVANCED QUALITY PREGNANCY TEST

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

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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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