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FDA 510(k)

HemosIL Factor XII Deficient Plasma

K-Number: K180486 · 2018-03-22

ApplicantInstrumentation Laboratory CO
Decision Date2018-03-22
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL Factor XII Deficient Plasma is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2018-03-22 under 510(k) number K180486. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemosIL Factor XII Deficient Plasma?

HemosIL Factor XII Deficient Plasma is a medical device that received FDA 510(k) clearance on 2018-03-22. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K180486.

When did HemosIL Factor XII Deficient Plasma receive FDA 510(k) clearance?

HemosIL Factor XII Deficient Plasma received FDA 510(k) clearance on 2018-03-22, under 510(k) number K180486.

Who is the listed applicant for HemosIL Factor XII Deficient Plasma?

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

What is the FDA product code for HemosIL Factor XII Deficient Plasma?

The FDA product code for HemosIL Factor XII Deficient Plasma is GJT.

Other records listing Instrumentation Laboratory CO as applicant

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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Related Devices (Code: GJT)

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

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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