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FDA 510(k)

VISION(R) PROTHROMBIN TIME

K-Number: K883441 · 1988-09-13

ApplicantAbbott Laboratories
Decision Date1988-09-13
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VISION(R) PROTHROMBIN TIME is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-09-13 under 510(k) number K883441. 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 VISION(R) PROTHROMBIN TIME?

VISION(R) PROTHROMBIN TIME is a medical device that received FDA 510(k) clearance on 1988-09-13. The listed applicant is Abbott Laboratories. The 510(k) number is K883441.

When did VISION(R) PROTHROMBIN TIME receive FDA 510(k) clearance?

VISION(R) PROTHROMBIN TIME received FDA 510(k) clearance on 1988-09-13, under 510(k) number K883441.

Who is the listed applicant for VISION(R) PROTHROMBIN TIME?

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

What is the FDA product code for VISION(R) PROTHROMBIN TIME?

The FDA product code for VISION(R) PROTHROMBIN TIME is GJS.

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Related Devices (Code: 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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