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FDA 510(k)

COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2

K-Number: K123726 · 2013-05-21

ApplicantRoche Diagnostics
Decision Date2013-05-21
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2013-05-21 under 510(k) number K123726. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2?

COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 is a medical device that received FDA 510(k) clearance on 2013-05-21. The listed applicant is Roche Diagnostics. The 510(k) number is K123726.

When did COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 receive FDA 510(k) clearance?

COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 received FDA 510(k) clearance on 2013-05-21, under 510(k) number K123726.

Who is the listed applicant for COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2?

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

What is the FDA product code for COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2?

The FDA product code for COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 is JGS.

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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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