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FDA 510(k)

INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST

K-Number: K994409 · 2000-07-10

ApplicantAlfa Scientific Designs, Inc.
Decision Date2000-07-10
Product CodeDPK
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2000-07-10 under 510(k) number K994409. The device is classified under product code DPK. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST?

INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST is a medical device that received FDA 510(k) clearance on 2000-07-10. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K994409.

When did INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST receive FDA 510(k) clearance?

INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST received FDA 510(k) clearance on 2000-07-10, under 510(k) number K994409.

Who is the listed applicant for INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST?

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

What is the FDA product code for INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST?

The FDA product code for INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST is DPK.

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Other records listing Alfa Scientific Designs, 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.

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Related Devices (Code: DPK)

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.

K994404INSTANT-VIEW MORPHINE URINE CASSETTE TESTAlfa Scientific Designs, Inc.

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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