Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE

K-Number: K830481 · 1983-03-24

ApplicantHoffmann-La Roche, Inc.
Decision Date1983-03-24
Product CodeLCL
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN RADIOIMMUNOASSAY-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 1983-03-24 under 510(k) number K830481. The device is classified under product code LCL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE?

ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE 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 K830481.

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

ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830481.

Who is the listed applicant for ABUSCREEN RADIOIMMUNOASSAY-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 RADIOIMMUNOASSAY-PHENCYCLIDINE?

The FDA product code for ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE is LCL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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--URINEK830480ABUSCREEN RADIOIMMUNOASSAY-COCAINE METAK830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEK830461ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE

View all 49 devices →

Related Devices (Code: LCL)

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.

K011275PSYCHEMEDICS RIA PHENCYCLIDINE ASSAYPsychemedics Corp.K994093AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25CPhamatechK913864PCP DIRECT RIA KIT (I-125)Immunalysis CorporationK890882ABUSCREEN 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.

↑