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FDA 510(k)

BECKMAN CHOLESTEROL REAGENT

K-Number: K934046 · 1993-10-28

ApplicantBeckman-Diagnostic Systems Group
Decision Date1993-10-28
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BECKMAN CHOLESTEROL REAGENT 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 1993-10-28 under 510(k) number K934046. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN CHOLESTEROL REAGENT?

BECKMAN CHOLESTEROL REAGENT is a medical device that received FDA 510(k) clearance on 1993-10-28. The listed applicant is Beckman-Diagnostic Systems Group. The 510(k) number is K934046.

When did BECKMAN CHOLESTEROL REAGENT receive FDA 510(k) clearance?

BECKMAN CHOLESTEROL REAGENT received FDA 510(k) clearance on 1993-10-28, under 510(k) number K934046.

Who is the listed applicant for BECKMAN CHOLESTEROL REAGENT?

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 BECKMAN CHOLESTEROL REAGENT?

The FDA product code for BECKMAN CHOLESTEROL REAGENT is CHH.

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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 SYSTEMK944606CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMSK942676SYNCHRON CX3 DELTAK934293BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT

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Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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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