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FDA 510(k)

DBEST OPIATES TEST KIT

K-Number: K983190 · 1998-11-18

ApplicantAmeritek, Inc.
Decision Date1998-11-18
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DBEST OPIATES TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ameritek, Inc.. It received FDA 510(k) clearance on 1998-11-18 under 510(k) number K983190. 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 DBEST OPIATES TEST KIT?

DBEST OPIATES TEST KIT is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Ameritek, Inc.. The 510(k) number is K983190.

When did DBEST OPIATES TEST KIT receive FDA 510(k) clearance?

DBEST OPIATES TEST KIT received FDA 510(k) clearance on 1998-11-18, under 510(k) number K983190.

Who is the listed applicant for DBEST OPIATES TEST KIT?

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

What is the FDA product code for DBEST OPIATES TEST KIT?

The FDA product code for DBEST OPIATES TEST KIT is DJG.

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Other records listing Ameritek, Inc. as applicant

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Related Devices (Code: DJG)

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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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