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FDA 510(k)

VERDICT OPIATES

K-Number: K943712 · 1994-11-17

ApplicantEditek, Inc.
Decision Date1994-11-17
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VERDICT OPIATES is the device name listed in this FDA 510(k) record. The listed applicant is Editek, Inc.. It received FDA 510(k) clearance on 1994-11-17 under 510(k) number K943712. 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 VERDICT OPIATES?

VERDICT OPIATES is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Editek, Inc.. The 510(k) number is K943712.

When did VERDICT OPIATES receive FDA 510(k) clearance?

VERDICT OPIATES received FDA 510(k) clearance on 1994-11-17, under 510(k) number K943712.

Who is the listed applicant for VERDICT OPIATES?

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

What is the FDA product code for VERDICT OPIATES?

The FDA product code for VERDICT OPIATES is DJG.

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Other records listing Editek, 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.

K963692VERDICT PCPK963233EZ-SCREEN PROFILEK963516VERDICT THCK963529VERDICT BARBITURATESK943710VERDICT COCAINEK943711EZ-SCREEN:PCP

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Related Devices (Code: DJG)

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

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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