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FDA 510(k)

IMX CKMB

K-Number: K883013 · 1988-08-08

ApplicantAbbott Laboratories
Decision Date1988-08-08
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMX CKMB is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-08-08 under 510(k) number K883013. 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 IMX CKMB?

IMX CKMB is a medical device that received FDA 510(k) clearance on 1988-08-08. The listed applicant is Abbott Laboratories. The 510(k) number is K883013.

When did IMX CKMB receive FDA 510(k) clearance?

IMX CKMB received FDA 510(k) clearance on 1988-08-08, under 510(k) number K883013.

Who is the listed applicant for IMX CKMB?

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

What is the FDA product code for IMX CKMB?

The FDA product code for IMX CKMB is JHY.

Other records listing Abbott Laboratories as applicant

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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 LaboratoriesK022654MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MBRoche Diagnostics Corp.K974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, 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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