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FDA 510(k)

ABUSCREEN RADIOIMMUNOASSAY-COCAINE META

K-Number: K830480 · 1983-03-24

ApplicantHoffmann-La Roche, Inc.
Decision Date1983-03-24
Product CodeKLN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN RADIOIMMUNOASSAY-COCAINE META is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830480. The device is classified under product code KLN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN RADIOIMMUNOASSAY-COCAINE META?

ABUSCREEN RADIOIMMUNOASSAY-COCAINE META is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K830480.

When did ABUSCREEN RADIOIMMUNOASSAY-COCAINE META receive FDA 510(k) clearance?

ABUSCREEN RADIOIMMUNOASSAY-COCAINE META received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830480.

Who is the listed applicant for ABUSCREEN RADIOIMMUNOASSAY-COCAINE META?

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

What is the FDA product code for ABUSCREEN RADIOIMMUNOASSAY-COCAINE META?

The FDA product code for ABUSCREEN RADIOIMMUNOASSAY-COCAINE META is KLN.

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Other records listing Hoffmann-La Roche, 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.

K850727BHCG-ROCHE EIAK831694RENAKK830462ABUSCREEN RADIOUMMUNOASSAY--URINEK830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEK830461ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONEK830481ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE

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Related Devices (Code: KLN)

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.

K010868PSYCHEMEDICS RIA COCAINE ASSAYPsychemedics Corp.K913867URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)Immunalysis CorporationK913722ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K912756ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K910123TARGET COCAINE METABOLITE-VV-Tech, Inc.K910122TARGET COCAINE METABOLITE-RV-Tech, 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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