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FDA 510(k)

ROCHE ISOMUNE- CK

K-Number: K903025 · 1990-08-09

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-08-09
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE ISOMUNE- CK is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-08-09 under 510(k) number K903025. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE ISOMUNE- CK?

ROCHE ISOMUNE- CK is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K903025.

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

ROCHE ISOMUNE- CK received FDA 510(k) clearance on 1990-08-09, under 510(k) number K903025.

Who is the listed applicant for ROCHE ISOMUNE- CK?

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

What is the FDA product code for ROCHE ISOMUNE- CK?

The FDA product code for ROCHE ISOMUNE- CK is JHS.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: JHS)

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.

K160570Creatine KinaseRoche Diagnostics Operations (Rdo)K102706CKMB UDR ASSAYSENTINEL CH. SpAK082226S40 CREATINE KINASE (CK)Alfa Wassermann Diagnostic Technologies, Inc.K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990434CARESIDE CKMBCareside, Inc.K990439CARESIDE CKCareside, 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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