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FDA 510(k)

DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA

K-Number: K972337 · 1997-08-08

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1997-08-08
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1997-08-08 under 510(k) number K972337. 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 DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA?

DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA is a medical device that received FDA 510(k) clearance on 1997-08-08. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K972337.

When did DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA receive FDA 510(k) clearance?

DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA received FDA 510(k) clearance on 1997-08-08, under 510(k) number K972337.

Who is the listed applicant for DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA?

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

What is the FDA product code for DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA?

The FDA product code for DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA is JIR.

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Other records listing Diagnostic Chemicals , Ltd. 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.

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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

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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