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)

SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE

K-Number: K864646 · 1987-01-05

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1987-01-05
Product CodeGKF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1987-01-05 under 510(k) number K864646. The device is classified under product code GKF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE?

SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE is a medical device that received FDA 510(k) clearance on 1987-01-05. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K864646.

When did SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE receive FDA 510(k) clearance?

SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE received FDA 510(k) clearance on 1987-01-05, under 510(k) number K864646.

Who is the listed applicant for SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE?

The FDA product code for SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE is GKF.

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 E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

View all 253 devices →

Related Devices (Code: GKF)

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.

K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)Instrumentation Laboratory COK983551CRIT-SCAN II MONITORIn-Line Diagnostics Corp.K981427STAT PROFILE M ANALYZERNova Biomedical Corp.K981425STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERSNova Biomedical Corp.K981426STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERSNova Biomedical Corp.K953519MICROSPIN 24Vulcon Technologies

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.

↑