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FDA 510(k)

IMX(R) STAT CK-MB

K-Number: K931172 · 1993-06-15

ApplicantAbbott Laboratories
Decision Date1993-06-15
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMX(R) STAT CK-MB is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1993-06-15 under 510(k) number K931172. 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(R) STAT CK-MB?

IMX(R) STAT CK-MB is a medical device that received FDA 510(k) clearance on 1993-06-15. The listed applicant is Abbott Laboratories. The 510(k) number is K931172.

When did IMX(R) STAT CK-MB receive FDA 510(k) clearance?

IMX(R) STAT CK-MB received FDA 510(k) clearance on 1993-06-15, under 510(k) number K931172.

Who is the listed applicant for IMX(R) STAT CK-MB?

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(R) STAT CK-MB?

The FDA product code for IMX(R) STAT CK-MB 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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