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FDA 510(k)

ROCHO ISOMUNE - LD

K-Number: K894081 · 1989-08-31

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1989-08-31
Product CodeCFE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHO ISOMUNE - LD 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 1989-08-31 under 510(k) number K894081. The device is classified under product code CFE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHO ISOMUNE - LD?

ROCHO ISOMUNE - LD is a medical device that received FDA 510(k) clearance on 1989-08-31. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K894081.

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

ROCHO ISOMUNE - LD received FDA 510(k) clearance on 1989-08-31, under 510(k) number K894081.

Who is the listed applicant for ROCHO ISOMUNE - LD?

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 ROCHO ISOMUNE - LD?

The FDA product code for ROCHO ISOMUNE - LD is CFE.

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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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