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FDA 510(k)

COBAS CORE FERRITIN EIA

K-Number: K920829 · 1992-06-19

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1992-06-19
Product CodeJMG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COBAS CORE FERRITIN EIA is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1992-06-19 under 510(k) number K920829. 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 COBAS CORE FERRITIN EIA?

COBAS CORE FERRITIN EIA is a medical device that received FDA 510(k) clearance on 1992-06-19. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K920829.

When did COBAS CORE FERRITIN EIA receive FDA 510(k) clearance?

COBAS CORE FERRITIN EIA received FDA 510(k) clearance on 1992-06-19, under 510(k) number K920829.

Who is the listed applicant for COBAS CORE FERRITIN EIA?

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

What is the FDA product code for COBAS CORE FERRITIN EIA?

The FDA product code for COBAS CORE FERRITIN EIA 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.K052082FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020Beckman 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.

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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