Hemocue B-Glucose System
FDA 510(k) K943432 · Hemocue, Inc.
510(k) numberK943432
Submission
- Device name
- Hemocue B-Glucose System
- Applicant
- Hemocue, Inc.
Mission Viejo, CA, US - Received
- July 15, 1994
- Decision date
- January 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K252488 | ABL90 FLEX PLUS SystemCGA · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K210933 | YSI 2900C Biochemistry AnalyzerCGA · Traditional | Ysi, Inc. | 09/30/2024SE |
| K220328 | EasyStat 300CGA · Traditional | Medica Corporation | 07/26/2024SE |
| K223179 | Cholestech LDX SystemCGA · Dual Track | Alere San Diego, Inc. | 09/20/2023SE |
| K223755 | i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 09/11/2023SE |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 07/28/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | Instrumentation Laboratory CO | 01/27/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 10/18/2022SE |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 08/13/2021SE |
| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 03/13/2020SE |
More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K201217 | HemoCue Hb 301 SystemGKR · Traditional | 08/04/2020SE |
| K181751 | HemoCue Hb 801 SystemGKR · Traditional | 02/01/2019SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | 10/25/2007SE |
| K060765 | Hemocue Glucose 201 RT Analyzer MDL 120731, Hemocue Glucose 201 RT Microcurettes MDL…LFR · Traditional | 09/06/2006SE |
| K061047 | Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801GKR · Traditional | 06/08/2006SE |
| K053253 | Hemocue Albumin 201 Analyzing SystemKQO · Traditional | 02/17/2006SE |
| K041234 | Hemocue Hemoglobin 201DM Analyzing SystemGKR · Special | 06/10/2004SE |
| K041230 | Clinical Laboratory Analyzing SystemLFR · Special | 05/20/2004SE |
| K032203 | Hemocue Hemoglobin 201 + System Article 121704GKR · Special | 08/25/2003SE |
| K020935 | Hemocue Glucose 201 System, Article Number 120706CGA · Special | 04/03/2002SE |
Questions and answers
When was Hemocue B-Glucose System cleared by the FDA?
Hemocue B-Glucose System (K943432) received a 510(k) decision of Substantially Equivalent on January 17, 1995, 186 days after the submission was received.
What is the product code of K943432?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.