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FDA 510(k)

COBAS CORE IMMUNOCHEMISTRY SYSTEM

K-Number: K921180 · 1992-07-28

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1992-07-28
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS CORE IMMUNOCHEMISTRY SYSTEM 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 1992-07-28 under 510(k) number K921180. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS CORE IMMUNOCHEMISTRY SYSTEM?

COBAS CORE IMMUNOCHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K921180.

When did COBAS CORE IMMUNOCHEMISTRY SYSTEM receive FDA 510(k) clearance?

COBAS CORE IMMUNOCHEMISTRY SYSTEM received FDA 510(k) clearance on 1992-07-28, under 510(k) number K921180.

Who is the listed applicant for COBAS CORE IMMUNOCHEMISTRY SYSTEM?

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 COBAS CORE IMMUNOCHEMISTRY SYSTEM?

The FDA product code for COBAS CORE IMMUNOCHEMISTRY SYSTEM is JJQ.

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Related Devices (Code: JJQ)

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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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