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FDA 510(k)

CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM

K-Number: K944605 · 1994-12-07

ApplicantBeckman-Diagnostic Systems Group
Decision Date1994-12-07
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Beckman-Diagnostic Systems Group. It received FDA 510(k) clearance on 1994-12-07 under 510(k) number K944605. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM?

CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-07. The listed applicant is Beckman-Diagnostic Systems Group. The 510(k) number is K944605.

When did CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM receive FDA 510(k) clearance?

CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM received FDA 510(k) clearance on 1994-12-07, under 510(k) number K944605.

Who is the listed applicant for CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM?

The FDA 510(k) record lists Beckman-Diagnostic Systems Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM?

The FDA product code for CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM is LCM.

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Other records listing Beckman-Diagnostic Systems Group 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.

K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSK944604CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMSK944606CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMSK942676SYNCHRON CX3 DELTAK934293BECKMAN PANCREATIC AMYLASE (PAMY) REAGENTK934068BECKMAN DIRECT BILIRUBIN REAGENT

View all 11 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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