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)

QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED

K-Number: K891907 · 1989-04-11

ApplicantR&D Systems, Inc.
Decision Date1989-04-11
Product CodeJCN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 1989-04-11 under 510(k) number K891907. The device is classified under product code JCN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED?

QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED is a medical device that received FDA 510(k) clearance on 1989-04-11. The listed applicant is R&D Systems, Inc.. The 510(k) number is K891907.

When did QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED receive FDA 510(k) clearance?

QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED received FDA 510(k) clearance on 1989-04-11, under 510(k) number K891907.

Who is the listed applicant for QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED?

The FDA 510(k) record lists R&D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED?

The FDA product code for QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED is JCN.

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 R&D Systems, 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.

K160606BC-5D Hematology ControlK130962R&D 5D RETIC HEMATOLOGY CONTROLK101578R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROLK100050R & D SYSTEMS XERET HEMATOLOGY CONTROLK091433R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROLK073178HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

View all 79 devices →

Related Devices (Code: JCN)

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.

K993825PARA TECH PLUS RETICSStreck Laboratories, Inc.K942209LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGHBio-RadK934497CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLER&D Systems, Inc.K911582STAK-CHEXStreck Laboratories, Inc.K902391CELL-DYN 3000 CONTROLUnipath , Ltd.K902389TRI-COUNT 16Hematronix, Inc.

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.

↑