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FDA 510(k)

MICROALBUSTIX REAGENT STRIPS (OTC)

K-Number: K991315 · 1999-11-12

ApplicantBayer Corp.
Decision Date1999-11-12
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROALBUSTIX REAGENT STRIPS (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1999-11-12 under 510(k) number K991315. 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 MICROALBUSTIX REAGENT STRIPS (OTC)?

MICROALBUSTIX REAGENT STRIPS (OTC) is a medical device that received FDA 510(k) clearance on 1999-11-12. The listed applicant is Bayer Corp.. The 510(k) number is K991315.

When did MICROALBUSTIX REAGENT STRIPS (OTC) receive FDA 510(k) clearance?

MICROALBUSTIX REAGENT STRIPS (OTC) received FDA 510(k) clearance on 1999-11-12, under 510(k) number K991315.

Who is the listed applicant for MICROALBUSTIX REAGENT STRIPS (OTC)?

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

What is the FDA product code for MICROALBUSTIX REAGENT STRIPS (OTC)?

The FDA product code for MICROALBUSTIX REAGENT STRIPS (OTC) is JIR.

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Other records listing Bayer Corp. as applicant

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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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