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FDA 510(k)

ISE INDIRECT NA, K, CL FOR GEN.2

K-Number: K053165 · 2005-12-14

ApplicantRoche Diagnostics Corp.
Decision Date2005-12-14
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISE INDIRECT NA, K, CL FOR GEN.2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2005-12-14 under 510(k) number K053165. 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 ISE INDIRECT NA, K, CL FOR GEN.2?

ISE INDIRECT NA, K, CL FOR GEN.2 is a medical device that received FDA 510(k) clearance on 2005-12-14. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K053165.

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

ISE INDIRECT NA, K, CL FOR GEN.2 received FDA 510(k) clearance on 2005-12-14, under 510(k) number K053165.

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

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

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

The FDA product code for ISE INDIRECT NA, K, CL 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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