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FDA 510(k)

AQ ONE STEP COCAINE TEST

K-Number: K972384 · 1997-08-06

ApplicantBionike Laboratories, Inc.
Decision Date1997-08-06
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AQ ONE STEP COCAINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bionike Laboratories, Inc.. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K972384. 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 AQ ONE STEP COCAINE TEST?

AQ ONE STEP COCAINE TEST is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Bionike Laboratories, Inc.. The 510(k) number is K972384.

When did AQ ONE STEP COCAINE TEST receive FDA 510(k) clearance?

AQ ONE STEP COCAINE TEST received FDA 510(k) clearance on 1997-08-06, under 510(k) number K972384.

Who is the listed applicant for AQ ONE STEP COCAINE TEST?

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

What is the FDA product code for AQ ONE STEP COCAINE TEST?

The FDA product code for AQ ONE STEP COCAINE TEST is DIO.

Related Clinical Trials

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Other records listing Bionike Laboratories, 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.

K993945BIONIKE AQ PHENCYCLIDINE (PCP) TESTK971841BIONIKE AQ ONE STEP CANNABINOIDS (THC) TESTK971361AQ OPIATES (MORPHINE) TESTK960992BIONIKE A/Q PREGNANCY TESTK954901BIONIKE A/Q PREGNANCY TEST

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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