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FDA 510(k)

ELECSYS PRECICONTROL UNIVERSAL

K-Number: K051687 · 2005-07-25

ApplicantRoche Diagnostics Corp.
Decision Date2005-07-25
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 Corp.. It received FDA 510(k) clearance on 2005-07-25 under 510(k) number K051687. 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 2005-07-25. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K051687.

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

ELECSYS PRECICONTROL UNIVERSAL received FDA 510(k) clearance on 2005-07-25, under 510(k) number K051687.

Who is the listed applicant for ELECSYS PRECICONTROL UNIVERSAL?

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 PRECICONTROL UNIVERSAL?

The FDA product code for ELECSYS PRECICONTROL UNIVERSAL is JJY.

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Other records listing Roche Diagnostics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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Related Devices (Code: 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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