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FDA 510(k)

IMX HOMOCYSTEINE

K-Number: K980812 · 1998-10-01

ApplicantAxis Biochemicals, Asa
Decision Date1998-10-01
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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 1998-10-01 under 510(k) number K980812. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMX HOMOCYSTEINE?

IMX HOMOCYSTEINE is a medical device that received FDA 510(k) clearance on 1998-10-01. The listed applicant is Axis Biochemicals, Asa. The 510(k) number is K980812.

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

IMX HOMOCYSTEINE received FDA 510(k) clearance on 1998-10-01, under 510(k) number K980812.

Who is the listed applicant for 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 IMX HOMOCYSTEINE?

The FDA product code for IMX HOMOCYSTEINE is DFC.

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.

K992274MODIFICATION TO IMX HOMOCYSTEINEK980907AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY

Related Devices (Code: DFC)

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.

K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.K241220Tina-quant Lipoprotein(a) Gen.2 MolarityRoche Diagnostics OperationsK211058Lp(a) UltraSENTINEL CH. SpAK180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics, Inc.K122722COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics

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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