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FDA 510(k)

AQ OPIATES (MORPHINE) TEST

K-Number: K971361 · 1997-06-06

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

Device Summary

AQ OPIATES (MORPHINE) 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 1997-06-06 under 510(k) number K971361. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQ OPIATES (MORPHINE) TEST?

AQ OPIATES (MORPHINE) TEST is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Bionike Laboratories, Inc.. The 510(k) number is K971361.

When did AQ OPIATES (MORPHINE) TEST receive FDA 510(k) clearance?

AQ OPIATES (MORPHINE) TEST received FDA 510(k) clearance on 1997-06-06, under 510(k) number K971361.

Who is the listed applicant for AQ OPIATES (MORPHINE) 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 OPIATES (MORPHINE) TEST?

The FDA product code for AQ OPIATES (MORPHINE) TEST is DJG.

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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 TESTK971841BIONIKE AQ ONE STEP CANNABINOIDS (THC) TESTK960992BIONIKE A/Q PREGNANCY TESTK954901BIONIKE A/Q PREGNANCY TEST

Related Devices (Code: DJG)

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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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