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)

DIAGLAZE

K-Number: K822142 · 1982-09-14

ApplicantAntraco, Inc.
Decision Date1982-09-14
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIAGLAZE is the device name listed in this FDA 510(k) record. The listed applicant is Antraco, Inc.. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822142. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGLAZE?

DIAGLAZE is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Antraco, Inc.. The 510(k) number is K822142.

When did DIAGLAZE receive FDA 510(k) clearance?

DIAGLAZE received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822142.

Who is the listed applicant for DIAGLAZE?

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

What is the FDA product code for DIAGLAZE?

The FDA product code for DIAGLAZE is EJR.

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 Antraco, 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.

K822894DIABRITE

Related Devices (Code: EJR)

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.

K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.AK121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINDentsply International, Inc.K103114OSSPRAY SYLC CROsspray, Ltd.K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTESunstar Americas, Inc.K101104REMIN PROVoco GmbHK100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, 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.

↑