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FDA 510(k)

QUIKPAC II ONE STEP OPIATE TEST

K-Number: K972405 · 1997-08-08

ApplicantDrial Consultants, Inc.
Decision Date1997-08-08
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUIKPAC II ONE STEP OPIATE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Drial Consultants, Inc.. It received FDA 510(k) clearance on 1997-08-08 under 510(k) number K972405. 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 QUIKPAC II ONE STEP OPIATE TEST?

QUIKPAC II ONE STEP OPIATE TEST is a medical device that received FDA 510(k) clearance on 1997-08-08. The listed applicant is Drial Consultants, Inc.. The 510(k) number is K972405.

When did QUIKPAC II ONE STEP OPIATE TEST receive FDA 510(k) clearance?

QUIKPAC II ONE STEP OPIATE TEST received FDA 510(k) clearance on 1997-08-08, under 510(k) number K972405.

Who is the listed applicant for QUIKPAC II ONE STEP OPIATE TEST?

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

What is the FDA product code for QUIKPAC II ONE STEP OPIATE TEST?

The FDA product code for QUIKPAC II ONE STEP OPIATE TEST is DJG.

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Other records listing Drial Consultants, Inc. as applicant

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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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