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FDA 510(k)

EZ-SCREEN:PCP

K-Number: K943711 · 1994-09-09

ApplicantEditek, Inc.
Decision Date1994-09-09
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

EZ-SCREEN:PCP is the device name listed in this FDA 510(k) record. The listed applicant is Editek, Inc.. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K943711. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-SCREEN:PCP?

EZ-SCREEN:PCP is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Editek, Inc.. The 510(k) number is K943711.

When did EZ-SCREEN:PCP receive FDA 510(k) clearance?

EZ-SCREEN:PCP received FDA 510(k) clearance on 1994-09-09, under 510(k) number K943711.

Who is the listed applicant for EZ-SCREEN:PCP?

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

What is the FDA product code for EZ-SCREEN:PCP?

The FDA product code for EZ-SCREEN:PCP is LCM.

Related Clinical Trials

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Other records listing Editek, 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.

K963692VERDICT PCPK963233EZ-SCREEN PROFILEK963516VERDICT THCK963529VERDICT BARBITURATESK943712VERDICT OPIATESK943710VERDICT COCAINE

View all 7 devices →

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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