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FDA 510(k)

ACE(TM) CEDIA(R) FERRITIN ASSAY

K-Number: K950393 · 1995-05-16

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1995-05-16
Product CodeJMG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACE(TM) CEDIA(R) FERRITIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Schiapparelli Biosystems, Inc.. It received FDA 510(k) clearance on 1995-05-16 under 510(k) number K950393. 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 ACE(TM) CEDIA(R) FERRITIN ASSAY?

ACE(TM) CEDIA(R) FERRITIN ASSAY is a medical device that received FDA 510(k) clearance on 1995-05-16. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K950393.

When did ACE(TM) CEDIA(R) FERRITIN ASSAY receive FDA 510(k) clearance?

ACE(TM) CEDIA(R) FERRITIN ASSAY received FDA 510(k) clearance on 1995-05-16, under 510(k) number K950393.

Who is the listed applicant for ACE(TM) CEDIA(R) FERRITIN ASSAY?

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

What is the FDA product code for ACE(TM) CEDIA(R) FERRITIN ASSAY?

The FDA product code for ACE(TM) CEDIA(R) FERRITIN ASSAY 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.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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