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FDA 510(k)

ALBUWELL

K-Number: K884146 · 1989-01-23

ApplicantExocell, Inc.
Decision Date1989-01-23
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUWELL is the device name listed in this FDA 510(k) record. The listed applicant is Exocell, Inc.. It received FDA 510(k) clearance on 1989-01-23 under 510(k) number K884146. 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 ALBUWELL?

ALBUWELL is a medical device that received FDA 510(k) clearance on 1989-01-23. The listed applicant is Exocell, Inc.. The 510(k) number is K884146.

When did ALBUWELL receive FDA 510(k) clearance?

ALBUWELL received FDA 510(k) clearance on 1989-01-23, under 510(k) number K884146.

Who is the listed applicant for ALBUWELL?

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 ALBUWELL?

The FDA product code for ALBUWELL is JIR.

Related Clinical Trials

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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.DIALK893453GLYCABENK891544DIALBUMIN

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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