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FDA 510(k)

ELECSYS PRECICONTROL BONE

K-Number: K051543 · 2005-10-17

ApplicantRoche Diagnostics Corp.
Decision Date2005-10-17
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS PRECICONTROL BONE 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 2005-10-17 under 510(k) number K051543. 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 BONE?

ELECSYS PRECICONTROL BONE is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K051543.

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

ELECSYS PRECICONTROL BONE received FDA 510(k) clearance on 2005-10-17, under 510(k) number K051543.

Who is the listed applicant for ELECSYS PRECICONTROL BONE?

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 BONE?

The FDA product code for ELECSYS PRECICONTROL BONE 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.

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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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