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FDA 510(k)

MODIFICATION TO IMX HOMOCYSTEINE

K-Number: K992274 · 1999-10-06

ApplicantAxis Biochemicals, Asa
Decision Date1999-10-06
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO IMX HOMOCYSTEINE 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 1999-10-06 under 510(k) number K992274. 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 MODIFICATION TO IMX HOMOCYSTEINE?

MODIFICATION TO IMX HOMOCYSTEINE is a medical device that received FDA 510(k) clearance on 1999-10-06. The listed applicant is Axis Biochemicals, Asa. The 510(k) number is K992274.

When did MODIFICATION TO IMX HOMOCYSTEINE receive FDA 510(k) clearance?

MODIFICATION TO IMX HOMOCYSTEINE received FDA 510(k) clearance on 1999-10-06, under 510(k) number K992274.

Who is the listed applicant for MODIFICATION TO IMX HOMOCYSTEINE?

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 MODIFICATION TO IMX HOMOCYSTEINE?

The FDA product code for MODIFICATION TO IMX HOMOCYSTEINE is LPS.

Related Clinical Trials

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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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.

K980907AXIS HOMOCYSTEINE ENZYME IMMUNOASSAYK980812IMX 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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