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FDA 510(k)

LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621

K-Number: K081683 · 2008-07-07

ApplicantSiemens Healthcare Diagnostics
Decision Date2008-07-07
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2008-07-07 under 510(k) number K081683. 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 LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621?

LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 is a medical device that received FDA 510(k) clearance on 2008-07-07. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K081683.

When did LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 receive FDA 510(k) clearance?

LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 received FDA 510(k) clearance on 2008-07-07, under 510(k) number K081683.

Who is the listed applicant for LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621?

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

What is the FDA product code for LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621?

The FDA product code for LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 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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