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FDA 510(k)

UROTEST GPH

K-Number: K912244 · 1991-11-22

ApplicantIn Wha Pharmaceutical Co., Ltd.
Decision Date1991-11-22
Product CodeJII
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

UROTEST GPH is the device name listed in this FDA 510(k) record. The listed applicant is In Wha Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K912244. The device is classified under product code JII. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROTEST GPH?

UROTEST GPH is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is In Wha Pharmaceutical Co., Ltd.. The 510(k) number is K912244.

When did UROTEST GPH receive FDA 510(k) clearance?

UROTEST GPH received FDA 510(k) clearance on 1991-11-22, under 510(k) number K912244.

Who is the listed applicant for UROTEST GPH?

The FDA 510(k) record lists In Wha Pharmaceutical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROTEST GPH?

The FDA product code for UROTEST GPH is JII.

Related Clinical Trials

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Related Devices (Code: JII)

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.

K082001DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116BDiazyme LaboratoriesK033360DIAZYME LITHIUM ENZYMATIC ASSAY KITGeneral Atomics

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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