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FDA 510(k)

TARGET MICROALBUMINURIA TEST

K-Number: K912246 · 1991-07-19

ApplicantTexas Immunology, Inc.
Decision Date1991-07-19
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TARGET MICROALBUMINURIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1991-07-19 under 510(k) number K912246. 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 TARGET MICROALBUMINURIA TEST?

TARGET MICROALBUMINURIA TEST is a medical device that received FDA 510(k) clearance on 1991-07-19. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K912246.

When did TARGET MICROALBUMINURIA TEST receive FDA 510(k) clearance?

TARGET MICROALBUMINURIA TEST received FDA 510(k) clearance on 1991-07-19, under 510(k) number K912246.

Who is the listed applicant for TARGET MICROALBUMINURIA TEST?

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

What is the FDA product code for TARGET MICROALBUMINURIA TEST?

The FDA product code for TARGET MICROALBUMINURIA TEST is JIR.

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Other records listing Texas Immunology, Inc. 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.

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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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