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FDA 510(k)

MICRO ALBUMIN EIA TEST KIT

K-Number: K912543 · 1991-07-19

ApplicantImmuno Diagnostic Center, Inc.
Decision Date1991-07-19
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICRO ALBUMIN EIA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Diagnostic Center, Inc.. It received FDA 510(k) clearance on 1991-07-19 under 510(k) number K912543. 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 MICRO ALBUMIN EIA TEST KIT?

MICRO ALBUMIN EIA TEST KIT is a medical device that received FDA 510(k) clearance on 1991-07-19. The listed applicant is Immuno Diagnostic Center, Inc.. The 510(k) number is K912543.

When did MICRO ALBUMIN EIA TEST KIT receive FDA 510(k) clearance?

MICRO ALBUMIN EIA TEST KIT received FDA 510(k) clearance on 1991-07-19, under 510(k) number K912543.

Who is the listed applicant for MICRO ALBUMIN EIA TEST KIT?

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

What is the FDA product code for MICRO ALBUMIN EIA TEST KIT?

The FDA product code for MICRO ALBUMIN EIA TEST KIT 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.

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Other records listing Immuno Diagnostic Center, 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.

K923195MYOGLOBIN ELISA TEST KITK904038MYOGLOBIN RIA TEST KIT

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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