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FDA 510(k)

ONE STEP MORPHINE CARD TEST

K-Number: K970579 · 1997-07-03

ApplicantTeco Diagnostics
Decision Date1997-07-03
Product CodeDNK
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONE STEP MORPHINE CARD TEST is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K970579. The device is classified under product code DNK. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE STEP MORPHINE CARD TEST?

ONE STEP MORPHINE CARD TEST is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Teco Diagnostics. The 510(k) number is K970579.

When did ONE STEP MORPHINE CARD TEST receive FDA 510(k) clearance?

ONE STEP MORPHINE CARD TEST received FDA 510(k) clearance on 1997-07-03, under 510(k) number K970579.

Who is the listed applicant for ONE STEP MORPHINE CARD TEST?

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

What is the FDA product code for ONE STEP MORPHINE CARD TEST?

The FDA product code for ONE STEP MORPHINE CARD TEST is DNK.

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Other records listing Teco Diagnostics 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: DNK)

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.

K853140MDI QUIK TEST NARCOTICS DRUG SCREENMedical Diagnostics, Ca.

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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