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)

ST-4 COAGULATION INSTRUMENT

K-Number: K904297 · 1990-11-13

ApplicantAmerican Bioproducts Co.
Decision Date1990-11-13
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ST-4 COAGULATION INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1990-11-13 under 510(k) number K904297. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST-4 COAGULATION INSTRUMENT?

ST-4 COAGULATION INSTRUMENT is a medical device that received FDA 510(k) clearance on 1990-11-13. The listed applicant is American Bioproducts Co.. The 510(k) number is K904297.

When did ST-4 COAGULATION INSTRUMENT receive FDA 510(k) clearance?

ST-4 COAGULATION INSTRUMENT received FDA 510(k) clearance on 1990-11-13, under 510(k) number K904297.

Who is the listed applicant for ST-4 COAGULATION INSTRUMENT?

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

What is the FDA product code for ST-4 COAGULATION INSTRUMENT?

The FDA product code for ST-4 COAGULATION INSTRUMENT is GKP.

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 American Bioproducts 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.

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERK971519ASSERACHROM TPA TEST KITK964728STA-LIATEST D-DI TEST KITK964716STA LIATEST CONTROL [N]+[P] KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST KIT

View all 79 devices →

Related Devices (Code: GKP)

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.

K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)Instrumentation Laboratory (IL) Co.K231031ACL TOP Family 70 SeriesInstrumentation Laboratory CompanyK160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)Instrumentation Laboratory COK091980ACL TOP 700 LASInstrumentation Laboratory COK073377ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)Instrumentation Laboratory COK063679ACL TOPInstrumentation 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.

↑