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FDA 510(k)

BECKMAN DIRECT BILIRUBIN REAGENT

K-Number: K934068 · 1994-04-26

ApplicantBeckman-Diagnostic Systems Group
Decision Date1994-04-26
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BECKMAN DIRECT BILIRUBIN 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 1994-04-26 under 510(k) number K934068. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN DIRECT BILIRUBIN REAGENT?

BECKMAN DIRECT BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Beckman-Diagnostic Systems Group. The 510(k) number is K934068.

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

BECKMAN DIRECT BILIRUBIN REAGENT received FDA 510(k) clearance on 1994-04-26, under 510(k) number K934068.

Who is the listed applicant for BECKMAN DIRECT BILIRUBIN 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 DIRECT BILIRUBIN REAGENT?

The FDA product code for BECKMAN DIRECT BILIRUBIN REAGENT is CIG.

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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: CIG)

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.

K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223324Total Bilirubin2Abbott Ireland Diagnostics DivisionK190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup

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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