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FDA 510(k)

HIM TEST COCAINE

K-Number: K792429 · 1979-12-07

ApplicantTecknam, Inc.
Decision Date1979-12-07
Product CodeDLN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

HIM TEST COCAINE is the device name listed in this FDA 510(k) record. The listed applicant is Tecknam, Inc.. It received FDA 510(k) clearance on 1979-12-07 under 510(k) number K792429. The device is classified under product code DLN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIM TEST COCAINE?

HIM TEST COCAINE is a medical device that received FDA 510(k) clearance on 1979-12-07. The listed applicant is Tecknam, Inc.. The 510(k) number is K792429.

When did HIM TEST COCAINE receive FDA 510(k) clearance?

HIM TEST COCAINE received FDA 510(k) clearance on 1979-12-07, under 510(k) number K792429.

Who is the listed applicant for HIM TEST COCAINE?

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

What is the FDA product code for HIM TEST COCAINE?

The FDA product code for HIM TEST COCAINE is DLN.

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Related Devices (Code: DLN)

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.

K950134URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGEE.I. Dupont DE Nemours & Co., Inc.K924113ABUSCREEN ONLINE FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K760401COCAINE KIT, TOXI-PAKJ.T. Baker Chemical Co.

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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