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FDA 510(k)

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

K-Number: K112790 · 2012-05-07

ApplicantAxis-Shield Diagnostics, Ltd.
Decision Date2012-05-07
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2012-05-07 under 510(k) number K112790. 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 AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON?

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON is a medical device that received FDA 510(k) clearance on 2012-05-07. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K112790.

When did AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON receive FDA 510(k) clearance?

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON received FDA 510(k) clearance on 2012-05-07, under 510(k) number K112790.

Who is the listed applicant for AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON?

The FDA 510(k) record lists Axis-Shield Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON?

The FDA product code for AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON is LPS.

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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 TESTRocheK083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100Axis-Shield Diagnostics, Ltd.K080851A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAYAnticancer, Inc.

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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