FDA 510(k)

ABUSCREEN RIA FOR PHENCYCLIDINE

K-Number: K790655 · 1979-06-15

Decision Date1979-06-15

Product CodeLCL

DecisionSubstantially Equivalent

Device Summary

ABUSCREEN RIA FOR PHENCYCLIDINE 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 1979-06-15 under 510(k) number K790655. The device is classified under product code LCL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN RIA FOR PHENCYCLIDINE?

ABUSCREEN RIA FOR PHENCYCLIDINE is a medical device that received FDA 510(k) clearance on 1979-06-15. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K790655.

When did ABUSCREEN RIA FOR PHENCYCLIDINE receive FDA 510(k) clearance?

ABUSCREEN RIA FOR PHENCYCLIDINE received FDA 510(k) clearance on 1979-06-15, under 510(k) number K790655.

Who is the listed applicant for ABUSCREEN RIA FOR PHENCYCLIDINE?

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 RIA FOR PHENCYCLIDINE?

The FDA product code for ABUSCREEN RIA FOR PHENCYCLIDINE is LCL.

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Other records listing Hoffmann-La Roche, Inc. as applicant

K850727BHCG-ROCHE EIA K831694RENAK K830462ABUSCREEN RADIOUMMUNOASSAY--URINE K830480ABUSCREEN RADIOIMMUNOASSAY-COCAINE META K830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE K830461ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE

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Related Devices (Code: LCL)

K011275PSYCHEMEDICS RIA PHENCYCLIDINE ASSAYPsychemedics Corp.K994093AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25CPhamatech K913864PCP DIRECT RIA KIT (I-125)Immunalysis Corporation K890882ABUSCREEN FP FOR PHENCYCLIDINERoche Diagnostic Systems, Inc.K882179EMIT HVA PHENCYCLIDINE ASSAYSyva Co.K880011REVISED LABELING FOR ADX PHENCYCLIDINEAbbott Laboratories

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.