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FDA 510(k)

A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY

K-Number: K080851 · 2008-10-10

ApplicantAnticancer, Inc.
Decision Date2008-10-10
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Anticancer, Inc.. It received FDA 510(k) clearance on 2008-10-10 under 510(k) number K080851. 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 A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY?

A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY is a medical device that received FDA 510(k) clearance on 2008-10-10. The listed applicant is Anticancer, Inc.. The 510(k) number is K080851.

When did A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY receive FDA 510(k) clearance?

A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY received FDA 510(k) clearance on 2008-10-10, under 510(k) number K080851.

Who is the listed applicant for A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY?

The FDA 510(k) record lists Anticancer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY?

The FDA product code for A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY is LPS.

Related Clinical Trials

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Other records listing Anticancer, Inc. 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.

K111260A/C ENZYMATIC VITAMIN B6 ASSAYK030754A/C ENZYMATIC HOMOCYSTEINE ASSAY

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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