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)

COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY

K-Number: K915083 · 1992-01-03

ApplicantKabi Pharmacia, Inc.
Decision Date1992-01-03
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Kabi Pharmacia, Inc.. It received FDA 510(k) clearance on 1992-01-03 under 510(k) number K915083. 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 COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY?

COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY is a medical device that received FDA 510(k) clearance on 1992-01-03. The listed applicant is Kabi Pharmacia, Inc.. The 510(k) number is K915083.

When did COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY receive FDA 510(k) clearance?

COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY received FDA 510(k) clearance on 1992-01-03, under 510(k) number K915083.

Who is the listed applicant for COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY?

The FDA 510(k) record lists Kabi Pharmacia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY?

The FDA product code for COAMATE(R) ANTITHROMBIN CHROMOGENIC 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 Kabi Pharmacia, Inc. 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.

K923832PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION

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.

↑