Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR

K-Number: K061296 · 2006-06-13

ApplicantDiazyme Laboratories
Decision Date2006-06-13
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2006-06-13 under 510(k) number K061296. 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 DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR?

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR is a medical device that received FDA 510(k) clearance on 2006-06-13. The listed applicant is Diazyme Laboratories. The 510(k) number is K061296.

When did DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR receive FDA 510(k) clearance?

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR received FDA 510(k) clearance on 2006-06-13, under 510(k) number K061296.

Who is the listed applicant for DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR?

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

What is the FDA product code for DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR?

The FDA product code for DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Diazyme Laboratories 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.

K172992Diazyme EZ Vitamin D AssayK163418Diazyme DZ-Lite Total beta-hCG Test SystemK162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetK160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetK153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorK161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

View all 38 devices →

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.

↑