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)

TRI-COUNT CALIBRATOR

K-Number: K844708 · 1985-03-05

ApplicantHematology Marketing Assoc.
Decision Date1985-03-05
Product CodeKSA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TRI-COUNT CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hematology Marketing Assoc.. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K844708. The device is classified under product code KSA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-COUNT CALIBRATOR?

TRI-COUNT CALIBRATOR is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is Hematology Marketing Assoc.. The 510(k) number is K844708.

When did TRI-COUNT CALIBRATOR receive FDA 510(k) clearance?

TRI-COUNT CALIBRATOR received FDA 510(k) clearance on 1985-03-05, under 510(k) number K844708.

Who is the listed applicant for TRI-COUNT CALIBRATOR?

The FDA 510(k) record lists Hematology Marketing Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRI-COUNT CALIBRATOR?

The FDA product code for TRI-COUNT CALIBRATOR is KSA.

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 Hematology Marketing Assoc. 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.

K851843OSMOCEL 3K851375TRI-COUNTK850095LASER-DILK850096LASER-GLOBINK850097LASER-LYSEK850094LASER-GLOBIN POWDER

View all 14 devices →

Related Devices (Code: KSA)

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.

K943268SCS-1000 (SYSMEX CALIBRATOR SYSTEM)Streck Laboratories, Inc.K897060CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLER&D Systems, Inc.K881161TECH-CAL(TM)/MULTIPLER&D Systems, Inc.K864664H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORSTechnicon Instruments Corp.K854823CBC-CAL/MULTIPLER&D Systems, Inc.K813530HEMOTOLOGY CALIBRATORAmerican Dade

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.

↑