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FDA 510(k)

LIGHTCYCLER INSTRUMENT VERSION 1.2

K-Number: K033734 · 2003-12-17

ApplicantRoche Diagnostics Corp.
Decision Date2003-12-17
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIGHTCYCLER INSTRUMENT VERSION 1.2 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 2003-12-17 under 510(k) number K033734. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHTCYCLER INSTRUMENT VERSION 1.2?

LIGHTCYCLER INSTRUMENT VERSION 1.2 is a medical device that received FDA 510(k) clearance on 2003-12-17. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K033734.

When did LIGHTCYCLER INSTRUMENT VERSION 1.2 receive FDA 510(k) clearance?

LIGHTCYCLER INSTRUMENT VERSION 1.2 received FDA 510(k) clearance on 2003-12-17, under 510(k) number K033734.

Who is the listed applicant for LIGHTCYCLER INSTRUMENT VERSION 1.2?

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 LIGHTCYCLER INSTRUMENT VERSION 1.2?

The FDA product code for LIGHTCYCLER INSTRUMENT VERSION 1.2 is JJF.

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Related Devices (Code: JJF)

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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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