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FDA 510(k)

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

K-Number: K022654 · 2002-08-29

ApplicantRoche Diagnostics Corp.
Decision Date2002-08-29
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB 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 2002-08-29 under 510(k) number K022654. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB?

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB is a medical device that received FDA 510(k) clearance on 2002-08-29. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K022654.

When did MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB receive FDA 510(k) clearance?

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB received FDA 510(k) clearance on 2002-08-29, under 510(k) number K022654.

Who is the listed applicant for MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB?

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 MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB?

The FDA product code for MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB is JHY.

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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: JHY)

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.

K132571ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche DiagnosticsK070835OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (IrishK022757SPIFE CK KIT, MODEL 3332, 3333Helena LaboratoriesK974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, Inc.K961412CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITROBayer 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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