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FDA 510(k)

PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH

K-Number: K103099 · 2010-12-06

ApplicantRoche Diagnostics
Decision Date2010-12-06
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2010-12-06 under 510(k) number K103099. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH?

PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH is a medical device that received FDA 510(k) clearance on 2010-12-06. The listed applicant is Roche Diagnostics. The 510(k) number is K103099.

When did PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH receive FDA 510(k) clearance?

PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH received FDA 510(k) clearance on 2010-12-06, under 510(k) number K103099.

Who is the listed applicant for PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH?

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 HBA1C NORM; PRECICONTROL HBA1C PATH?

The FDA product code for PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH is JJX.

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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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