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FDA 510(k)

PRECICONTROL CLINCHEM MULTI 1 AND 2

K-Number: K102016 · 2010-09-01

ApplicantRoche Diagnostics
Decision Date2010-09-01
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECICONTROL CLINCHEM MULTI 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2010-09-01 under 510(k) number K102016. 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 PRECICONTROL CLINCHEM MULTI 1 AND 2?

PRECICONTROL CLINCHEM MULTI 1 AND 2 is a medical device that received FDA 510(k) clearance on 2010-09-01. The listed applicant is Roche Diagnostics. The 510(k) number is K102016.

When did PRECICONTROL CLINCHEM MULTI 1 AND 2 receive FDA 510(k) clearance?

PRECICONTROL CLINCHEM MULTI 1 AND 2 received FDA 510(k) clearance on 2010-09-01, under 510(k) number K102016.

Who is the listed applicant for PRECICONTROL CLINCHEM MULTI 1 AND 2?

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 PRECICONTROL CLINCHEM MULTI 1 AND 2?

The FDA product code for PRECICONTROL CLINCHEM MULTI 1 AND 2 is JJY.

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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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