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FDA 510(k)

HemosIL Silica Clotting Time

K-Number: K253957 · 2026-01-09

Decision Date2026-01-09
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL Silica Clotting Time is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory (IL) Co.. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K253957. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemosIL Silica Clotting Time?

HemosIL Silica Clotting Time is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is Instrumentation Laboratory (IL) Co.. The 510(k) number is K253957.

When did HemosIL Silica Clotting Time receive FDA 510(k) clearance?

HemosIL Silica Clotting Time received FDA 510(k) clearance on 2026-01-09, under 510(k) number K253957.

Who is the listed applicant for HemosIL Silica Clotting Time?

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

What is the FDA product code for HemosIL Silica Clotting Time?

The FDA product code for HemosIL Silica Clotting Time is GFO.

Other records listing Instrumentation Laboratory (IL) 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.

Related Devices (Code: GFO)

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.

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.