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FDA 510(k)

HEMOSIL SYNTHASIL

K-Number: K060688 · 2006-04-13

ApplicantInstrumentation Laboratory CO
Decision Date2006-04-13
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSIL SYNTHASIL 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 2006-04-13 under 510(k) number K060688. 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 SYNTHASIL?

HEMOSIL SYNTHASIL is a medical device that received FDA 510(k) clearance on 2006-04-13. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K060688.

When did HEMOSIL SYNTHASIL receive FDA 510(k) clearance?

HEMOSIL SYNTHASIL received FDA 510(k) clearance on 2006-04-13, under 510(k) number K060688.

Who is the listed applicant for HEMOSIL SYNTHASIL?

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 SYNTHASIL?

The FDA product code for HEMOSIL SYNTHASIL is GFO.

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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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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.

K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.K193556Cryocheck Hex LAPrecision BiologicK160445HemosIL Silica Clotting TimeInstrumentation Laboratory COK053111STA-CEPHASCREEN KITDiagnostica Stago, Inc.K050221HEMOSIL SILICA CLOTTING TIMEInstrumentation Laboratory COK022021VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTTVital Scientific N.V.

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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