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FDA 510(k)

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT

K-Number: K042448 · 2004-10-29

ApplicantGeneral Atomics
Decision Date2004-10-29
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is General Atomics. It received FDA 510(k) clearance on 2004-10-29 under 510(k) number K042448. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT?

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT is a medical device that received FDA 510(k) clearance on 2004-10-29. The listed applicant is General Atomics. The 510(k) number is K042448.

When did DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT receive FDA 510(k) clearance?

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT received FDA 510(k) clearance on 2004-10-29, under 510(k) number K042448.

Who is the listed applicant for DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT?

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

What is the FDA product code for DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT?

The FDA product code for DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT is JJX.

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Other records listing General Atomics 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.

K082488DIAZYME LP(A) ASSAYK072977DIAZYME APOLIPOPROTEIN A-1 ASSAYK072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSK050178HBA1C ENZYMATIC ASSAYK033360DIAZYME LITHIUM ENZYMATIC ASSAY KIT

Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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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