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)

GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY

K-Number: K850412 · 1985-05-08

ApplicantWarner-Lambert Co.
Decision Date1985-05-08
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Warner-Lambert Co.. It received FDA 510(k) clearance on 1985-05-08 under 510(k) number K850412. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY?

GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY is a medical device that received FDA 510(k) clearance on 1985-05-08. The listed applicant is Warner-Lambert Co.. The 510(k) number is K850412.

When did GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY receive FDA 510(k) clearance?

GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY received FDA 510(k) clearance on 1985-05-08, under 510(k) number K850412.

Who is the listed applicant for GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY?

The FDA 510(k) record lists Warner-Lambert Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY?

The FDA product code for GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY is JBQ.

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 Warner-Lambert Co. 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.

K024160NEOSPORIN SCAR SOLUTIONK893452EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAMK870584O.P.T.(TM) OVULATION PREDICTION TESTK861510MULTILUMEN VIAPIC CENTRAL LINE CATHETERK852967GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISKK852689GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK

View all 50 devices →

Related Devices (Code: JBQ)

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.

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbHK081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare DiagnosticsK070301HEMOSIL ANTITHROMBINInstrumentation Laboratory COK062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory COK043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen BiomedK033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation Laboratory CO

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.

↑