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FDA 510(k)

THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.

K-Number: K896625 · 1989-12-11

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1989-12-11
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1989-12-11 under 510(k) number K896625. 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 THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.?

THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. is a medical device that received FDA 510(k) clearance on 1989-12-11. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K896625.

When did THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. receive FDA 510(k) clearance?

THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. received FDA 510(k) clearance on 1989-12-11, under 510(k) number K896625.

Who is the listed applicant for THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.?

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

What is the FDA product code for THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.?

The FDA product code for THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. is GJS.

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Other records listing Medical Diagnostic Technologies, Inc. as applicant

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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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