Glucose Reagent Kit
FDA 510(k) K873128 · A-Kem, Inc.
510(k) numberK873128
Submission
- Device name
- Glucose Reagent Kit
- Applicant
- A-Kem, Inc.
Clifton, NJ, US - Received
- August 10, 1987
- Decision date
- October 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| 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 |
|---|---|---|
| K884224 | Total Bilirubin Reagent Kit for Astra SystemsCIG · Traditional | 12/15/1988SE |
| K884227 | Calibrator Standard Kit for Astra SystemJIX · Traditional | 12/09/1988SE |
| K884226 | Amylase Reagent Kit for Astra SystemsCJA · Traditional | 12/09/1988SE |
| K884225 | Total Protein Reagent Kit for Astra SystemsCEK · Traditional | 12/09/1988SE |
| K882587 | A-Kem Albumin Reagent Kit for Astra SystemCIX · Traditional | 08/08/1988SE |
| K882586 | A-Kem Calcium Reagent Kit for Astra SystemCIC · Traditional | 08/08/1988SE |
| K873132 | Bun Reagent KitLFP · Traditional | 10/23/1987SE |
| K873131 | Creatinine Reagent KitCGX · Traditional | 10/23/1987SE |
| K873130 | Wash Solution KitJJE · Traditional | 10/23/1987SE |
| K873129 | Carbon Dioxide Reagent KitJFL · Traditional | 10/23/1987SE |
Questions and answers
When was Glucose Reagent Kit cleared by the FDA?
Glucose Reagent Kit (K873128) received a 510(k) decision of Substantially Equivalent on October 23, 1987, 74 days after the submission was received.
What is the product code of K873128?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.