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FDA 510(k)

ISOMUNE-CK

K-Number: K810905 · 1981-04-14

ApplicantHoffmann-La Roche, Inc.
Decision Date1981-04-14
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISOMUNE-CK is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1981-04-14 under 510(k) number K810905. 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 ISOMUNE-CK?

ISOMUNE-CK is a medical device that received FDA 510(k) clearance on 1981-04-14. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K810905.

When did ISOMUNE-CK receive FDA 510(k) clearance?

ISOMUNE-CK received FDA 510(k) clearance on 1981-04-14, under 510(k) number K810905.

Who is the listed applicant for ISOMUNE-CK?

The FDA 510(k) record lists Hoffmann-La Roche, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOMUNE-CK?

The FDA product code for ISOMUNE-CK is JHW.

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Other records listing Hoffmann-La Roche, Inc. 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.

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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 SaicK003158ROCHE DIAGNOSTICS CK-MBRoche Diagnostics Corp.K961501ELECSYS CK-MBBoehringer Mannheim Corp.K950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMiles, 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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