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)

R&D CBC-XE HEMATOLOGY CONTROL

K-Number: K042094 · 2004-09-01

ApplicantR&D Systems, Inc.
Decision Date2004-09-01
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

R&D CBC-XE HEMATOLOGY CONTROL 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 2004-09-01 under 510(k) number K042094. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R&D CBC-XE HEMATOLOGY CONTROL?

R&D CBC-XE HEMATOLOGY CONTROL is a medical device that received FDA 510(k) clearance on 2004-09-01. The listed applicant is R&D Systems, Inc.. The 510(k) number is K042094.

When did R&D CBC-XE HEMATOLOGY CONTROL receive FDA 510(k) clearance?

R&D CBC-XE HEMATOLOGY CONTROL received FDA 510(k) clearance on 2004-09-01, under 510(k) number K042094.

Who is the listed applicant for R&D CBC-XE HEMATOLOGY CONTROL?

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 R&D CBC-XE HEMATOLOGY CONTROL?

The FDA product code for R&D CBC-XE HEMATOLOGY CONTROL is JPK.

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: JPK)

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.

K160590XN CHECKStreckK160588XN CHECK BFStreckK160586XN-L CHECKStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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.

↑