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FDA 510(k)

THROMBO-TEST (X)

K-Number: K801054 · 1981-03-13

ApplicantMedtro GmbH
Decision Date1981-03-13
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBO-TEST (X) is the device name listed in this FDA 510(k) record. The listed applicant is Medtro GmbH. It received FDA 510(k) clearance on 1981-03-13 under 510(k) number K801054. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBO-TEST (X)?

THROMBO-TEST (X) is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is Medtro GmbH. The 510(k) number is K801054.

When did THROMBO-TEST (X) receive FDA 510(k) clearance?

THROMBO-TEST (X) received FDA 510(k) clearance on 1981-03-13, under 510(k) number K801054.

Who is the listed applicant for THROMBO-TEST (X)?

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

What is the FDA product code for THROMBO-TEST (X)?

The FDA product code for THROMBO-TEST (X) is JPK.

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Related Devices (Code: JPK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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