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FDA 510(k)

STANBIO CSF/URINE TOTAL PROTEIN TEST SET

K-Number: K902204 · 1990-08-22

ApplicantStanbio Laboratory
Decision Date1990-08-22
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STANBIO CSF/URINE TOTAL PROTEIN TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1990-08-22 under 510(k) number K902204. 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 STANBIO CSF/URINE TOTAL PROTEIN TEST SET?

STANBIO CSF/URINE TOTAL PROTEIN TEST SET is a medical device that received FDA 510(k) clearance on 1990-08-22. The listed applicant is Stanbio Laboratory. The 510(k) number is K902204.

When did STANBIO CSF/URINE TOTAL PROTEIN TEST SET receive FDA 510(k) clearance?

STANBIO CSF/URINE TOTAL PROTEIN TEST SET received FDA 510(k) clearance on 1990-08-22, under 510(k) number K902204.

Who is the listed applicant for STANBIO CSF/URINE TOTAL PROTEIN TEST SET?

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

What is the FDA product code for STANBIO CSF/URINE TOTAL PROTEIN TEST SET?

The FDA product code for STANBIO CSF/URINE TOTAL PROTEIN TEST SET is JIR.

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Other records listing Stanbio Laboratory 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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