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FDA 510(k)

ELECSYS TSH CALSET W/MODELS 04738551

K-Number: K060754 · 2006-04-18

ApplicantRoche Diagnostics Corp.
Decision Date2006-04-18
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS TSH CALSET W/MODELS 04738551 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 2006-04-18 under 510(k) number K060754. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS TSH CALSET W/MODELS 04738551?

ELECSYS TSH CALSET W/MODELS 04738551 is a medical device that received FDA 510(k) clearance on 2006-04-18. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K060754.

When did ELECSYS TSH CALSET W/MODELS 04738551 receive FDA 510(k) clearance?

ELECSYS TSH CALSET W/MODELS 04738551 received FDA 510(k) clearance on 2006-04-18, under 510(k) number K060754.

Who is the listed applicant for ELECSYS TSH CALSET W/MODELS 04738551?

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 ELECSYS TSH CALSET W/MODELS 04738551?

The FDA product code for ELECSYS TSH CALSET W/MODELS 04738551 is JIT.

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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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