Glucometer-E
FDA 510(k) K863102 · J. D. Assoc.
510(k) numberK863102
Submission
- Device name
- Glucometer-E
- Applicant
- J. D. Assoc.
Montclair, NJ, US - Received
- August 13, 1986
- Decision date
- November 24, 1986
- 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 |
|---|---|---|
| K863103 | Peg 6,000CHH · Traditional | 01/13/1987SE |
| K863054 | Ast S.C.E. (Got)CIT · Traditional | 01/13/1987SE |
| K863069 | MagnesiometerJGJ · Traditional | 12/31/1986SE |
| K863079 | CreatinkineticCGX · Traditional | 12/12/1986SE |
| K863112 | ProteinmeterJGP · Traditional | 12/10/1986SE |
| K863068 | LDH S.C.E.CFJ · Traditional | 12/10/1986SE |
| K863053 | Alt S.C.E. (GPT)CKA · Traditional | 12/10/1986SE |
| K863066 | TransfermeterJQF · Traditional | 12/04/1986SE |
| K863109 | FerrofastJIY · Traditional | 11/24/1986SE |
| K863056 | Bilirubin TotalCIG · Traditional | 11/24/1986SE |
Questions and answers
When was Glucometer-E cleared by the FDA?
Glucometer-E (K863102) received a 510(k) decision of Substantially Equivalent on November 24, 1986, 103 days after the submission was received.
What is the product code of K863102?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.