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FDA 510(k)

ROCHE STANDARDS FOR CHOLESTEROL

K-Number: K843110 · 1984-09-04

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1984-09-04
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE STANDARDS FOR CHOLESTEROL 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 1984-09-04 under 510(k) number K843110. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE STANDARDS FOR CHOLESTEROL?

ROCHE STANDARDS FOR CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1984-09-04. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K843110.

When did ROCHE STANDARDS FOR CHOLESTEROL receive FDA 510(k) clearance?

ROCHE STANDARDS FOR CHOLESTEROL received FDA 510(k) clearance on 1984-09-04, under 510(k) number K843110.

Who is the listed applicant for ROCHE STANDARDS FOR CHOLESTEROL?

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 STANDARDS FOR CHOLESTEROL?

The FDA product code for ROCHE STANDARDS FOR CHOLESTEROL is JIS.

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Related Devices (Code: JIS)

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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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