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FDA 510(k)

FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020

K-Number: K052082 · 2005-08-19

ApplicantBeckman Coulter, Inc.
Decision Date2005-08-19
Product CodeJMG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2005-08-19 under 510(k) number K052082. The device is classified under product code JMG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020?

FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 is a medical device that received FDA 510(k) clearance on 2005-08-19. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K052082.

When did FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 receive FDA 510(k) clearance?

FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 received FDA 510(k) clearance on 2005-08-19, under 510(k) number K052082.

Who is the listed applicant for FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020?

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

What is the FDA product code for FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020?

The FDA product code for FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 is JMG.

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Related Devices (Code: JMG)

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.

K234052Access FerritinBeckman Coulter, Inc.K964282TINA-QUANT FERRITIN ASSAYBoehringer Mannheim Corp.K971833ELECSYS FERRITINBoehringer Mannheim Corp.K963498FERR FLEX REAGENT CARTRIDGEDade Chemistry Systems, Inc.K950393ACE(TM) CEDIA(R) FERRITIN ASSAYSchiapparelli Biosystems, Inc.K925848IMMULITE FERRITINDiagnostic Products Corp.

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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