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FDA 510(k)

ENZIP URINARY MICROALBUMIN TEST

K-Number: K922032 · 1992-07-30

ApplicantDiagnostic Specialties
Decision Date1992-07-30
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZIP URINARY MICROALBUMIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Specialties. It received FDA 510(k) clearance on 1992-07-30 under 510(k) number K922032. 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 ENZIP URINARY MICROALBUMIN TEST?

ENZIP URINARY MICROALBUMIN TEST is a medical device that received FDA 510(k) clearance on 1992-07-30. The listed applicant is Diagnostic Specialties. The 510(k) number is K922032.

When did ENZIP URINARY MICROALBUMIN TEST receive FDA 510(k) clearance?

ENZIP URINARY MICROALBUMIN TEST received FDA 510(k) clearance on 1992-07-30, under 510(k) number K922032.

Who is the listed applicant for ENZIP URINARY MICROALBUMIN TEST?

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

What is the FDA product code for ENZIP URINARY MICROALBUMIN TEST?

The FDA product code for ENZIP URINARY MICROALBUMIN TEST is JIR.

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Other records listing Diagnostic Specialties 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.

K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITK941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITK930823PROTEIN-BOUND GLUCOSE ASSAYN KITK831180PREGNA-CERT, SLIDE PREGNANCY TESTK823109GENERIC PREGNANCY TESTK813608POTASSIUM REAGENT SET

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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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