Urotest GPH

FDA 510(k) K912244 · In Wha Pharmaceutical Co., Ltd.

Substantially Equivalent

510(k) numberK912244

Submission

Device name
Urotest GPH
Applicant
In Wha Pharmaceutical Co., Ltd.
Korea, KR
Received
May 21, 1991
Decision date
November 22, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JII – Atomic Absorption, Lithium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3560
Specialty
Clinical Toxicology

Other 510(k)s with product code JII

510(k)DeviceApplicantDecision
K082001Diazyme Liquid Stable Enzymatic Lithium Assay, Model DZ116BJII · Special Diazyme Laboratories12/05/2008SE
K033360Diazyme Lithium Enzymatic Assay KitJII · Traditional General Atomics12/23/2003SE

Questions and answers

When was Urotest GPH cleared by the FDA?

Urotest GPH (K912244) received a 510(k) decision of Substantially Equivalent on November 22, 1991, 185 days after the submission was received.

What is the product code of K912244?

The FDA product code is JII – Atomic Absorption, Lithium, a Class II (moderate risk) device regulated under 21 CFR 862.3560.