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FDA 510(k)

ELECSYS PRECICONTROL UNIVERSAL

K-Number: K090541 · 2009-07-02

ApplicantRoche Diagnostics
Decision Date2009-07-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS PRECICONTROL UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2009-07-02 under 510(k) number K090541. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS PRECICONTROL UNIVERSAL?

ELECSYS PRECICONTROL UNIVERSAL is a medical device that received FDA 510(k) clearance on 2009-07-02. The listed applicant is Roche Diagnostics. The 510(k) number is K090541.

When did ELECSYS PRECICONTROL UNIVERSAL receive FDA 510(k) clearance?

ELECSYS PRECICONTROL UNIVERSAL received FDA 510(k) clearance on 2009-07-02, under 510(k) number K090541.

Who is the listed applicant for ELECSYS PRECICONTROL UNIVERSAL?

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 PRECICONTROL UNIVERSAL?

The FDA product code for ELECSYS PRECICONTROL UNIVERSAL is JJY.

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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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