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FDA 510(k)

BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST

K-Number: K971841 · 1997-06-25

ApplicantBionike Laboratories, Inc.
Decision Date1997-06-25
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIONIKE AQ ONE STEP CANNABINOIDS (THC) 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 1997-06-25 under 510(k) number K971841. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST?

BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Bionike Laboratories, Inc.. The 510(k) number is K971841.

When did BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST receive FDA 510(k) clearance?

BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST received FDA 510(k) clearance on 1997-06-25, under 510(k) number K971841.

Who is the listed applicant for BIONIKE AQ ONE STEP CANNABINOIDS (THC) 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 BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST?

The FDA product code for BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST is LDJ.

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) TESTK972384AQ ONE STEP COCAINE TESTK971361AQ OPIATES (MORPHINE) TESTK960992BIONIKE A/Q PREGNANCY TESTK954901BIONIKE A/Q PREGNANCY TEST

Related Devices (Code: LDJ)

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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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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