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FDA 510(k)

ELECSYSCA 15-3 II ASSAY

K-Number: K010588 · 2001-03-28

ApplicantRoche Diagnostics Corp.
Decision Date2001-03-28
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELECSYSCA 15-3 II ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2001-03-28 under 510(k) number K010588. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYSCA 15-3 II ASSAY?

ELECSYSCA 15-3 II ASSAY is a medical device that received FDA 510(k) clearance on 2001-03-28. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K010588.

When did ELECSYSCA 15-3 II ASSAY receive FDA 510(k) clearance?

ELECSYSCA 15-3 II ASSAY received FDA 510(k) clearance on 2001-03-28, under 510(k) number K010588.

Who is the listed applicant for ELECSYSCA 15-3 II ASSAY?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECSYSCA 15-3 II ASSAY?

The FDA product code for ELECSYSCA 15-3 II ASSAY is MOI.

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Other records listing Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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Related Devices (Code: MOI)

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.

K240403Access BR MonitorBeckman Coulter, Inc.K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.K181492Elecsys CA 15-3 IIRoche Diagnostics

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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