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FDA 510(k)

CALCIUM GEN. 2

K-Number: K113521 · 2012-05-08

ApplicantRoche Diagnostics
Decision Date2012-05-08
Product CodeCHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM 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 2012-05-08 under 510(k) number K113521. The device is classified under product code CHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCIUM GEN. 2?

CALCIUM GEN. 2 is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Roche Diagnostics. The 510(k) number is K113521.

When did CALCIUM GEN. 2 receive FDA 510(k) clearance?

CALCIUM GEN. 2 received FDA 510(k) clearance on 2012-05-08, under 510(k) number K113521.

Who is the listed applicant for CALCIUM 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 CALCIUM GEN. 2?

The FDA product code for CALCIUM GEN. 2 is CHW.

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Related Devices (Code: CHW)

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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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