Who is the manufacturer of HCG STAT PAK ULTRA-FAST?

Chembio Diagnostic Systems, Inc. submitted the Special clearance for HCG STAT PAK ULTRA-FAST (K011550).

What is the FDA product code for HCG STAT PAK ULTRA-FAST?

JHI. It is classified under 21 CFR 862.1155 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for HCG STAT PAK ULTRA-FAST?

510(k) clearance (submission type: Special).

HCG STAT PAK ULTRA-FAST

K011550 · Chembio Diagnostic Systems, Inc. · JHI · Aug 14, 2001 · Clinical Chemistry

Device Facts

Record ID	K011550
Device Name	HCG STAT PAK ULTRA-FAST
Applicant	Chembio Diagnostic Systems, Inc.
Product Code	JHI · Clinical Chemistry
Decision Date	Aug 14, 2001
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1155
Device Class	Class 2

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.