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)

HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME

K-Number: K860122 · 1986-04-04

ApplicantMedical Device Consultants, Inc.
Decision Date1986-04-04
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Consultants, Inc.. It received FDA 510(k) clearance on 1986-04-04 under 510(k) number K860122. The device is classified under product code JBP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME?

HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME is a medical device that received FDA 510(k) clearance on 1986-04-04. The listed applicant is Medical Device Consultants, Inc.. The 510(k) number is K860122.

When did HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME receive FDA 510(k) clearance?

HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME received FDA 510(k) clearance on 1986-04-04, under 510(k) number K860122.

Who is the listed applicant for HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME?

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

What is the FDA product code for HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME?

The FDA product code for HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME is JBP.

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 Medical Device Consultants, 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.

K022895ELCAM STOPCOCKS AND MANIFOLDSK002699PARIETEX COMPOSITE (PCO) MESHK002116S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0K000551IMAGE X-70 PLUS DENTAL X-RAY UNITK974164SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBEK864282GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA

View all 14 devices →

Related Devices (Code: JBP)

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.

K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc.K062604RAPIDTEG TEG-ACT TESTHaemoscope Corp.K032952AIACT KITSienco, Inc.K023582I-STAT KAOLIN ACT TESTI-Stat CorporationK020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770Helena LaboratoriesK013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena Laboratories

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.

↑