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FDA 510(k)

ROCHE DIAGNOSTICS CK-MB

K-Number: K003158 · 2000-12-18

ApplicantRoche Diagnostics Corp.
Decision Date2000-12-18
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE DIAGNOSTICS 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 2000-12-18 under 510(k) number K003158. The device is classified under product code JHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE DIAGNOSTICS CK-MB?

ROCHE DIAGNOSTICS CK-MB is a medical device that received FDA 510(k) clearance on 2000-12-18. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K003158.

When did ROCHE DIAGNOSTICS CK-MB receive FDA 510(k) clearance?

ROCHE DIAGNOSTICS CK-MB received FDA 510(k) clearance on 2000-12-18, under 510(k) number K003158.

Who is the listed applicant for ROCHE DIAGNOSTICS 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 ROCHE DIAGNOSTICS CK-MB?

The FDA product code for ROCHE DIAGNOSTICS CK-MB is JHW.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: JHW)

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.

K162526Creatine Kinase-MBRoche DiagnosticsK122083ELITECH CLINICAL SYSTEMS CK NAC SLElitechgroupK023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354Wiener Laboratories SaicK961501ELECSYS CK-MBBoehringer Mannheim Corp.K950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMiles, Inc.K944325LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGNPrinceton BioMeditech 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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