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FDA 510(k)

CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS

K-Number: K944606 · 1994-11-30

ApplicantBeckman-Diagnostic Systems Group
Decision Date1994-11-30
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS 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 1994-11-30 under 510(k) number K944606. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS?

CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Beckman-Diagnostic Systems Group. The 510(k) number is K944606.

When did CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS receive FDA 510(k) clearance?

CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS received FDA 510(k) clearance on 1994-11-30, under 510(k) number K944606.

Who is the listed applicant for CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS?

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 OPIATE REAGENT FOR SYNCHRON CX SYSTEMS?

The FDA product code for CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS is DJG.

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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 SYSTEMSK944605CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEMK942676SYNCHRON CX3 DELTAK934293BECKMAN PANCREATIC AMYLASE (PAMY) REAGENTK934068BECKMAN DIRECT BILIRUBIN REAGENT

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Related Devices (Code: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, 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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