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FDA 510(k)

ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH

K-Number: K060585 · 2006-05-03

ApplicantRoche Diagnostics Corp.
Decision Date2006-05-03
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH 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 2006-05-03 under 510(k) number K060585. The device is classified under product code CKG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH?

ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH is a medical device that received FDA 510(k) clearance on 2006-05-03. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K060585.

When did ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH receive FDA 510(k) clearance?

ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH received FDA 510(k) clearance on 2006-05-03, under 510(k) number K060585.

Who is the listed applicant for ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH?

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 ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH?

The FDA product code for ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH is CKG.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: CKG)

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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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