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FDA 510(k)

ADX TM PHENCYCLIDINE

K-Number: K890688 · 1989-08-25

ApplicantAbbott Laboratories
Decision Date1989-08-25
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

ADX TM 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 1989-08-25 under 510(k) number K890688. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADX TM PHENCYCLIDINE?

ADX TM PHENCYCLIDINE is a medical device that received FDA 510(k) clearance on 1989-08-25. The listed applicant is Abbott Laboratories. The 510(k) number is K890688.

When did ADX TM PHENCYCLIDINE receive FDA 510(k) clearance?

ADX TM PHENCYCLIDINE received FDA 510(k) clearance on 1989-08-25, under 510(k) number K890688.

Who is the listed applicant for ADX TM 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 ADX TM PHENCYCLIDINE?

The FDA product code for ADX TM PHENCYCLIDINE is LCM.

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Related Devices (Code: LCM)

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.

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics CorporationK203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEOmega Laboratories, Inc.K122703RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTORBiophor Diagnostics, 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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