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FDA 510(k)

REVISED LABELING FOR TDX PHENCYCLIDINE

K-Number: K874484 · 1987-11-23

ApplicantAbbott Laboratories
Decision Date1987-11-23
Product CodeLCL
DecisionSubstantially Equivalent

Device Summary

REVISED LABELING FOR TDX PHENCYCLIDINE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K874484. The device is classified under product code LCL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVISED LABELING FOR TDX PHENCYCLIDINE?

REVISED LABELING FOR TDX PHENCYCLIDINE is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Abbott Laboratories. The 510(k) number is K874484.

When did REVISED LABELING FOR TDX PHENCYCLIDINE receive FDA 510(k) clearance?

REVISED LABELING FOR TDX PHENCYCLIDINE received FDA 510(k) clearance on 1987-11-23, under 510(k) number K874484.

Who is the listed applicant for REVISED LABELING FOR TDX PHENCYCLIDINE?

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

What is the FDA product code for REVISED LABELING FOR TDX PHENCYCLIDINE?

The FDA product code for REVISED LABELING FOR TDX PHENCYCLIDINE 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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