Accudata Glucose Test Station
FDA 510(k) K924475 · Boehringer Mannheim Corp.
510(k) numberK924475
Submission
- Device name
- Accudata Glucose Test Station
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- September 3, 1992
- Decision date
- October 13, 1992
- 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 |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Accudata Glucose Test Station cleared by the FDA?
Accudata Glucose Test Station (K924475) received a 510(k) decision of Substantially Equivalent on October 13, 1992, 40 days after the submission was received.
What is the product code of K924475?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.