Statzyme Glucose

FDA 510(k) K771001 · Worthington Biochemical Corp.

Substantially Equivalent

510(k) numberK771001

Submission

Device name
Statzyme Glucose
Applicant
Worthington Biochemical Corp.
Mchenry, IL, US
Received
June 3, 1977
Decision date
July 11, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CGA – Glucose Oxidase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

Other 510(k)s with product code CGA

510(k)DeviceApplicantDecision
K252488ABL90 FLEX PLUS SystemCGA · Traditional Radiometer Medicals Aps05/01/2026SE
K210933YSI 2900C Biochemistry AnalyzerCGA · Traditional Ysi, Inc.09/30/2024SE
K220328EasyStat 300CGA · Traditional Medica Corporation07/26/2024SE
K223179Cholestech LDX ™ SystemCGA · Dual Track Alere San Diego, Inc.09/20/2023SE
K223755i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.09/11/2023SE
K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.07/28/2023SE
K223090GEM Premier ChemSTATCGA · Special Instrumentation Laboratory CO01/27/2023SE
K203549Nova Primary Glucose Analyzer SystemCGA · Traditional Nova Biomedical Corporation10/18/2022SE
K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.08/13/2021SE
K200349Stat Profile Prime Plus Analyzer SystemCGA · Traditional Nova Biomedical Corporation03/13/2020SE

More from Nova Biomedical Corporation

510(k)DeviceDecision
K780389HDL Reagent Set for LipoproteinsCHH · Traditional 04/19/1978SE
K780096LDH Isoenzyme Control SerumJJY · Traditional 03/03/1978SE
K772356LDH Isoenzyme Column Reagent SetCEX · Traditional 01/24/1978SE
K772025Uric Acid Std. for Quant. Uric AcidJIS · Traditional 11/11/1977SE
K771143Inorganic Phosphorus StandardsJIT · Traditional 07/11/1977SE
K770831Statzyme Uric Acid ReagentCDO · Traditional 07/11/1977SE
K770470Worthington BunCDW · Traditional 06/02/1977SE
K770277Cholesterol StandardsJIT · Traditional 03/01/1977SE
K761263Cholesterol Automated ReagentCHH · Traditional 12/29/1976SE
K761262Triglycerides (Lipase) Reagent SetCDT · Traditional 12/29/1976SE

Questions and answers

When was Statzyme Glucose cleared by the FDA?

Statzyme Glucose (K771001) received a 510(k) decision of Substantially Equivalent on July 11, 1977, 38 days after the submission was received.

What is the product code of K771001?

The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.