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FDA 510(k)

AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY

K-Number: K980907 · 1998-10-16

ApplicantAxis Biochemicals, Asa
Decision Date1998-10-16
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Axis Biochemicals, Asa. It received FDA 510(k) clearance on 1998-10-16 under 510(k) number K980907. 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 HOMOCYSTEINE ENZYME IMMUNOASSAY?

AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1998-10-16. The listed applicant is Axis Biochemicals, Asa. The 510(k) number is K980907.

When did AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1998-10-16, under 510(k) number K980907.

Who is the listed applicant for AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY?

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

What is the FDA product code for AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY?

The FDA product code for AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY is LPS.

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Other records listing Axis Biochemicals, Asa 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.

K992274MODIFICATION TO IMX HOMOCYSTEINEK980812IMX HOMOCYSTEINE

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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