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 ASSAY BUFFER BASED CALIBRATORS

K-Number: K102638 · 2010-11-30

ApplicantDiazyme Laboratories
Decision Date2010-11-30
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2010-11-30 under 510(k) number K102638. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS?

DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS is a medical device that received FDA 510(k) clearance on 2010-11-30. The listed applicant is Diazyme Laboratories. The 510(k) number is K102638.

When did DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS receive FDA 510(k) clearance?

DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS received FDA 510(k) clearance on 2010-11-30, under 510(k) number K102638.

Who is the listed applicant for DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS?

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 ASSAY BUFFER BASED CALIBRATORS?

The FDA product code for DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS is JIT.

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: JIT)

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.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc.

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.

↑