Hemochek Urine Collection Kit

Q: What is the product code of K991800?

The FDA product code is JIQ – Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.

FDA 510(k) K991800 · Osborn Group, Inc.

Substantially Equivalent

510(k) numberK991800

Submission

Device name: Hemochek Urine Collection Kit
Applicant: Osborn Group, Inc.
Olathe, KS, US
Received: May 26, 1999
Decision date: September 24, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JIQ – Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Device class: Class I (low risk)
Regulation: 21 CFR 862.1645
Specialty: Clinical Chemistry

Other 510(k)s with product code JIQ

510(k)	Device	Applicant	Decision
K141925	Total Protein Urine/Csf GEN.3JIQ · Special	Roche Diagnostics Operations (Rdo)	12/09/2014SE
K013643	Ausam Total Albumin AssayJIQ · Traditional	Ausam Biotecthnologies, Inc.	08/14/2003SE
K971458	Enzip Immunoturbidimetric Microalbumin Assay KitJIQ · Traditional	Diagnostic Specialties	09/02/1997SE
K965035	Immage Immunochemistry System Microalbumin (Ma) ReagentJIQ · Traditional	Beckman Instruments, Inc.	04/17/1997SE
K944664	Wako Micro-Albumin B/Wako Micro Albumin CalibratorJIQ · Traditional	Wako Chemicals USA, Inc.	02/07/1995SE
K936202	Urinary Albumin Test PackJIQ · Traditional	Dupont Medical Products	05/09/1994SE
K935662	Synermed Ir 500 Chemistry AnalyzerJIQ · Traditional	Synermed, Inc.	04/26/1994SE
K903123	Raichem(Tm) Spia(Tm) Microalbulmin ReagentJIQ · Traditional	Reagents Applications, Inc.	09/14/1990SE
K902216	Wako(Tm) Micro-AlbuminJIQ · Traditional	Wako Chemicals USA, Inc.	06/18/1990SE
K895883	Beckman Ma Microalbumin Reagent KitJIQ · Traditional	Beckman Instruments, Inc.	12/27/1989SE

More from Beckman Instruments, Inc.

510(k)	Device	Decision
K002156	Appraise Urine Microalbumin Collection KitCGX · Traditional	12/19/2000SE
K993787	Appraise-Cardio Sample Collection KitJKA · Traditional	04/14/2000SE
K990899	HEMOCHEK-A1C Sample Collection KitLCP · Traditional	12/21/1999SE

Questions and answers

When was Hemochek Urine Collection Kit cleared by the FDA?

Hemochek Urine Collection Kit (K991800) received a 510(k) decision of Substantially Equivalent on September 24, 1999, 121 days after the submission was received.

What is the product code of K991800?

The FDA product code is JIQ – Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.