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)

GLUCOSE PROCEDURE, TEKPOINT DIRECT

K-Number: K770455 · 1977-05-03

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1977-05-03
Product CodeCGE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE PROCEDURE, TEKPOINT DIRECT is the device name listed in this FDA 510(k) record. The listed applicant is Icn Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1977-05-03 under 510(k) number K770455. The device is classified under product code CGE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE PROCEDURE, TEKPOINT DIRECT?

GLUCOSE PROCEDURE, TEKPOINT DIRECT is a medical device that received FDA 510(k) clearance on 1977-05-03. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K770455.

When did GLUCOSE PROCEDURE, TEKPOINT DIRECT receive FDA 510(k) clearance?

GLUCOSE PROCEDURE, TEKPOINT DIRECT received FDA 510(k) clearance on 1977-05-03, under 510(k) number K770455.

Who is the listed applicant for GLUCOSE PROCEDURE, TEKPOINT DIRECT?

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

What is the FDA product code for GLUCOSE PROCEDURE, TEKPOINT DIRECT?

The FDA product code for GLUCOSE PROCEDURE, TEKPOINT DIRECT is CGE.

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 Icn Pharmaceuticals, 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.

K022817COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-IIK951329IMMUCHEM GAL-MW EAK914530ICAN GT DRAINAGE BAGK914082SUAN FLAT DISSECTOR SPONGESK914083ICAN K DISSECTOR SPONGESK914081ICAN COTTON RAYON BALLS

View all 30 devices →

Related Devices (Code: CGE)

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.

K890335SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.Alpkem Corp.K855185GLUCOSE REAGENT SETTechnostics Intl.K850930GLUCOSEDilab, Inc.K841054DIRECT GLUCOSE REAGENT SETMedical Specialties, Inc.K821198DIRECT GLUCOSE REAGENT SETOmega Medical ElectronicsK811883KING DIAGNOSTICS GLUCOSE-O TESTKing Diagnostics, 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.

↑