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FDA 510(k)

ELECSYS PROBNP II CALCHECK 5

K-Number: K092169 · 2009-12-16

ApplicantRoche Diagnostics
Decision Date2009-12-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS PROBNP II CALCHECK 5 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2009-12-16 under 510(k) number K092169. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS PROBNP II CALCHECK 5?

ELECSYS PROBNP II CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2009-12-16. The listed applicant is Roche Diagnostics. The 510(k) number is K092169.

When did ELECSYS PROBNP II CALCHECK 5 receive FDA 510(k) clearance?

ELECSYS PROBNP II CALCHECK 5 received FDA 510(k) clearance on 2009-12-16, under 510(k) number K092169.

Who is the listed applicant for ELECSYS PROBNP II CALCHECK 5?

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 ELECSYS PROBNP II CALCHECK 5?

The FDA product code for ELECSYS PROBNP II CALCHECK 5 is JJX.

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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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