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FDA 510(k)

ROCHE COBAS MIRA PLUS

K-Number: K920402 · 1992-04-29

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1992-04-29
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE COBAS MIRA PLUS 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 1992-04-29 under 510(k) number K920402. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE COBAS MIRA PLUS?

ROCHE COBAS MIRA PLUS is a medical device that received FDA 510(k) clearance on 1992-04-29. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K920402.

When did ROCHE COBAS MIRA PLUS receive FDA 510(k) clearance?

ROCHE COBAS MIRA PLUS received FDA 510(k) clearance on 1992-04-29, under 510(k) number K920402.

Who is the listed applicant for ROCHE COBAS MIRA PLUS?

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 COBAS MIRA PLUS?

The FDA product code for ROCHE COBAS MIRA PLUS is JJE.

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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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