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FDA 510(k)

CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4

K-Number: K961807 · 1996-07-26

ApplicantCiba Corning Diagnostics Corp.
Decision Date1996-07-26
Product CodeGLK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Corning Diagnostics Corp.. It received FDA 510(k) clearance on 1996-07-26 under 510(k) number K961807. The device is classified under product code GLK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4?

CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 is a medical device that received FDA 510(k) clearance on 1996-07-26. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K961807.

When did CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 receive FDA 510(k) clearance?

CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 received FDA 510(k) clearance on 1996-07-26, under 510(k) number K961807.

Who is the listed applicant for CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4?

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

What is the FDA product code for CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4?

The FDA product code for CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 is GLK.

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 Ciba Corning Diagnostics Corp. 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.

K962559ACS CORTISOL IMMUNOASSAYK963251CIBA CORNING ACS;180 DPD ASSAYK961657CIBA CORNING 400 SYSTEMK962021CIBA CORNING 348 SYSTEMK962126ACS CKMB II IMMUNOASSAYK962041ACS LH2 IMMUNOASSAY

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Related Devices (Code: GLK)

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.

K121467EUROTROL HEMATOCRIT CONTROLEurotrol B.V.K021924MEDICA EASYQC HEMATOCRIT CONTROLBionostics, Inc.K020618AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROLAalto Scientific, Ltd.K964452HEMATACHEKRichmond Diagnostics, Inc.K924926MSI-HCTMedical Specialties, Inc.K893562A.QC HCT LEVEL 1 AND 2Johnson & Johnson Professionals, 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.

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