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FDA 510(k)

THC DIRECT RIA KIT

K-Number: K781048 · 1978-10-03

ApplicantImmunalysis Corporation
Decision Date1978-10-03
Product CodeLAT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THC DIRECT RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 1978-10-03 under 510(k) number K781048. The device is classified under product code LAT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THC DIRECT RIA KIT?

THC DIRECT RIA KIT is a medical device that received FDA 510(k) clearance on 1978-10-03. The listed applicant is Immunalysis Corporation. The 510(k) number is K781048.

When did THC DIRECT RIA KIT receive FDA 510(k) clearance?

THC DIRECT RIA KIT received FDA 510(k) clearance on 1978-10-03, under 510(k) number K781048.

Who is the listed applicant for THC DIRECT RIA KIT?

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

What is the FDA product code for THC DIRECT RIA KIT?

The FDA product code for THC DIRECT RIA KIT is LAT.

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Related Devices (Code: LAT)

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.

K011426PSYCHEMEDICS RIA CANNABINOID ASSAYPsychemedics Corp.K961620ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100Roche Diagnostic Systems, Inc.K936135SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATIONSudormed, Inc.K914507DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINEDiagnostic Products Corp.K913414ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KTRoche Diagnostic Systems, Inc.K913865URINE THC DIRECT RIA KIT (I-125)Immunalysis Corporation

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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