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FDA 510(k)

HOMOCYSTEINE TEST

K-Number: K113793 · 2012-06-05

ApplicantRoche
Decision Date2012-06-05
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HOMOCYSTEINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Roche. It received FDA 510(k) clearance on 2012-06-05 under 510(k) number K113793. 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 HOMOCYSTEINE TEST?

HOMOCYSTEINE TEST is a medical device that received FDA 510(k) clearance on 2012-06-05. The listed applicant is Roche. The 510(k) number is K113793.

When did HOMOCYSTEINE TEST receive FDA 510(k) clearance?

HOMOCYSTEINE TEST received FDA 510(k) clearance on 2012-06-05, under 510(k) number K113793.

Who is the listed applicant for HOMOCYSTEINE TEST?

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

What is the FDA product code for HOMOCYSTEINE TEST?

The FDA product code for HOMOCYSTEINE TEST is LPS.

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Other records listing Roche 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.

K102914TQ HBA1C GEN3

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.K112790AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONAxis-Shield Diagnostics, Ltd.K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100Axis-Shield Diagnostics, Ltd.K080851A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAYAnticancer, Inc.

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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