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FDA 510(k)

ACS 180 HOMOCYSTEINE ASSAY

K-Number: K013606 · 2001-12-21

ApplicantBayer Diagnostics Corp.
Decision Date2001-12-21
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACS 180 HOMOCYSTEINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2001-12-21 under 510(k) number K013606. 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 ACS 180 HOMOCYSTEINE ASSAY?

ACS 180 HOMOCYSTEINE ASSAY is a medical device that received FDA 510(k) clearance on 2001-12-21. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K013606.

When did ACS 180 HOMOCYSTEINE ASSAY receive FDA 510(k) clearance?

ACS 180 HOMOCYSTEINE ASSAY received FDA 510(k) clearance on 2001-12-21, under 510(k) number K013606.

Who is the listed applicant for ACS 180 HOMOCYSTEINE ASSAY?

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

What is the FDA product code for ACS 180 HOMOCYSTEINE ASSAY?

The FDA product code for ACS 180 HOMOCYSTEINE ASSAY is LPS.

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Other records listing Bayer Diagnostics Corp. 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.

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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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