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FDA 510(k)

PHENCYCLIDINE DIRECT BLOOD RIA KIT

K-Number: K800514 · 1980-03-19

ApplicantImmunalysis Corporation
Decision Date1980-03-19
Product CodeLCL
DecisionSubstantially Equivalent

Device Summary

PHENCYCLIDINE DIRECT BLOOD 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 1980-03-19 under 510(k) number K800514. The device is classified under product code LCL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHENCYCLIDINE DIRECT BLOOD RIA KIT?

PHENCYCLIDINE DIRECT BLOOD RIA KIT is a medical device that received FDA 510(k) clearance on 1980-03-19. The listed applicant is Immunalysis Corporation. The 510(k) number is K800514.

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

PHENCYCLIDINE DIRECT BLOOD RIA KIT received FDA 510(k) clearance on 1980-03-19, under 510(k) number K800514.

Who is the listed applicant for PHENCYCLIDINE DIRECT BLOOD 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 PHENCYCLIDINE DIRECT BLOOD RIA KIT?

The FDA product code for PHENCYCLIDINE DIRECT BLOOD RIA KIT is LCL.

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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.

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