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FDA 510(k)

RUBICON PROTHROMBIN TIME MONITORING SYSTEM

K-Number: K001699 · 2001-05-15

ApplicantLifescan, Inc.
Decision Date2001-05-15
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RUBICON PROTHROMBIN TIME MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 2001-05-15 under 510(k) number K001699. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBICON PROTHROMBIN TIME MONITORING SYSTEM?

RUBICON PROTHROMBIN TIME MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-15. The listed applicant is Lifescan, Inc.. The 510(k) number is K001699.

When did RUBICON PROTHROMBIN TIME MONITORING SYSTEM receive FDA 510(k) clearance?

RUBICON PROTHROMBIN TIME MONITORING SYSTEM received FDA 510(k) clearance on 2001-05-15, under 510(k) number K001699.

Who is the listed applicant for RUBICON PROTHROMBIN TIME MONITORING SYSTEM?

The FDA 510(k) record lists Lifescan, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBICON PROTHROMBIN TIME MONITORING SYSTEM?

The FDA product code for RUBICON PROTHROMBIN TIME MONITORING SYSTEM is GJS.

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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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