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)

WHITE BLOOD CELL COUNT CONTROL LEVELS

K-Number: K801265 · 1980-07-14

ApplicantBioscientific
Decision Date1980-07-14
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

WHITE BLOOD CELL COUNT CONTROL LEVELS is the device name listed in this FDA 510(k) record. The listed applicant is Bioscientific. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801265. 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 WHITE BLOOD CELL COUNT CONTROL LEVELS?

WHITE BLOOD CELL COUNT CONTROL LEVELS is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Bioscientific. The 510(k) number is K801265.

When did WHITE BLOOD CELL COUNT CONTROL LEVELS receive FDA 510(k) clearance?

WHITE BLOOD CELL COUNT CONTROL LEVELS received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801265.

Who is the listed applicant for WHITE BLOOD CELL COUNT CONTROL LEVELS?

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

What is the FDA product code for WHITE BLOOD CELL COUNT CONTROL LEVELS?

The FDA product code for WHITE BLOOD CELL COUNT CONTROL LEVELS 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 Bioscientific 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.

K812447AMYLASE REAGENT KITK811251CITRATE BUFFERK801267RED BLOOD CELL COUNT & HEMATOCRIT CNTLK801268HEMOGLOBIN CONTROL LEVELSK791658WRIGHT STAIN PACKK791007STAT DIFF STAIN

View all 16 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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-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.

↑