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FDA 510(k)

PROTHROMBIN TIME TEST

K-Number: K870596 · 1987-04-20

ApplicantU. S. Diagnostics, Inc.
Decision Date1987-04-20
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTHROMBIN TIME TEST is the device name listed in this FDA 510(k) record. The listed applicant is U. S. Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-04-20 under 510(k) number K870596. 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 PROTHROMBIN TIME TEST?

PROTHROMBIN TIME TEST is a medical device that received FDA 510(k) clearance on 1987-04-20. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K870596.

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

PROTHROMBIN TIME TEST received FDA 510(k) clearance on 1987-04-20, under 510(k) number K870596.

Who is the listed applicant for PROTHROMBIN TIME TEST?

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

What is the FDA product code for PROTHROMBIN TIME TEST?

The FDA product code for PROTHROMBIN TIME TEST is GJS.

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Other records listing U. S. Diagnostics, Inc. as applicant

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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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