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FDA 510(k)

COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE

K-Number: K851153 · 1985-11-05

ApplicantAstral Medical Systems
Decision Date1985-11-05
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE is the device name listed in this FDA 510(k) record. The listed applicant is Astral Medical Systems. It received FDA 510(k) clearance on 1985-11-05 under 510(k) number K851153. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE?

COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Astral Medical Systems. The 510(k) number is K851153.

When did COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE receive FDA 510(k) clearance?

COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE received FDA 510(k) clearance on 1985-11-05, under 510(k) number K851153.

Who is the listed applicant for COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE?

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

What is the FDA product code for COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE?

The FDA product code for COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE is JPA.

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 Astral Medical Systems 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.

K900506MODIFIED COATRON II AND COATRON JR.K853734APOLLO DENSITOMETERK851154ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18

Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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