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FDA 510(k)

DIALBUMIN

K-Number: K891544 · 1989-06-09

ApplicantExocell, Inc.
Decision Date1989-06-09
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Exocell, Inc.. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K891544. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALBUMIN?

DIALBUMIN is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Exocell, Inc.. The 510(k) number is K891544.

When did DIALBUMIN receive FDA 510(k) clearance?

DIALBUMIN received FDA 510(k) clearance on 1989-06-09, under 510(k) number K891544.

Who is the listed applicant for DIALBUMIN?

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

What is the FDA product code for DIALBUMIN?

The FDA product code for DIALBUMIN is JIR.

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 Exocell, 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.

K980888GLYCACORK894423ACC.U.DIALK893453GLYCABENK884146ALBUWELL

Related Devices (Code: JIR)

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.

K222921Minuteful-kidney testHealthy.Io, Ltd.K210069Minuteful - kidney testHealthy.Io, Ltd.K061419TECO MICROALBUMIN 2-1 COMBO STRIPSTeco DiagnosticsK022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25Diagnostic Chemicals, Ltd. (Usa)K001810URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTINGFlexsite Diagnostics, Inc.K994035IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15Diagnostic Chemicals , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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