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FDA 510(k)

HEMOSIL HOMOCYSTEINE AND CONTROLS

K-Number: K061598 · 2006-09-22

ApplicantInstrumentation Laboratory CO
Decision Date2006-09-22
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMOSIL HOMOCYSTEINE AND CONTROLS 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 2006-09-22 under 510(k) number K061598. The device is classified under product code LPS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSIL HOMOCYSTEINE AND CONTROLS?

HEMOSIL HOMOCYSTEINE AND CONTROLS is a medical device that received FDA 510(k) clearance on 2006-09-22. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K061598.

When did HEMOSIL HOMOCYSTEINE AND CONTROLS receive FDA 510(k) clearance?

HEMOSIL HOMOCYSTEINE AND CONTROLS received FDA 510(k) clearance on 2006-09-22, under 510(k) number K061598.

Who is the listed applicant for HEMOSIL HOMOCYSTEINE AND CONTROLS?

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 HOMOCYSTEINE AND CONTROLS?

The FDA product code for HEMOSIL HOMOCYSTEINE AND CONTROLS is LPS.

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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: LPS)

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.

K123930VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K121053DIAZYME HOMOCYSTEINE POC TEST KITDiazyme LaboratoriesK121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETTosoh Bioscience, Inc.K113793HOMOCYSTEINE TESTRocheK112790AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONAxis-Shield Diagnostics, Ltd.K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100Axis-Shield Diagnostics, Ltd.

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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