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)

CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE

K-Number: K852516 · 1985-07-15

ApplicantWhittaker General Medical
Decision Date1985-07-15
Product CodeJPI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker General Medical. It received FDA 510(k) clearance on 1985-07-15 under 510(k) number K852516. The device is classified under product code JPI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE?

CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE is a medical device that received FDA 510(k) clearance on 1985-07-15. The listed applicant is Whittaker General Medical. The 510(k) number is K852516.

When did CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE receive FDA 510(k) clearance?

CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE received FDA 510(k) clearance on 1985-07-15, under 510(k) number K852516.

Who is the listed applicant for CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE?

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

What is the FDA product code for CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE?

The FDA product code for CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE is JPI.

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

Related Devices (Code: JPI)

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.

K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K163342i-STAT Hematocrit test with i-STAT Alinity SystemAbbott LaboratoriesK950942CRIT-LINE HEMATOCRIT ALERTIn-Line Diagnostics Corp.K924167CRIT-LINENoninvasive Medical Technology Corp.K903698STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBESStatspin TechnologiesK902028STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READERNorfolk Scientific, 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.

↑