Apec Glucose Analyzer
FDA 510(k) K890524 · Amdev, Inc.
510(k) numberK890524
Submission
- Device name
- Apec Glucose Analyzer
- Applicant
- Amdev, Inc.
Danvers, MA, US - Received
- February 2, 1989
- Decision date
- March 15, 1989
- 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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| 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 |
|---|---|---|
| K904726 | Lytening TM 6/RJFP · Traditional | 12/18/1990SE |
| K884731 | Lytening 6 Sodium/Potassium/Ionized Calcium AnalyzJFP · Traditional | 02/03/1989SE |
| K880917 | Lytening 5JGS · Traditional | 05/27/1988SE |
| K863521 | Lytening 2JGS · Traditional | 11/05/1986SE |
| K853832 | Lytening 1JGS · Traditional | 10/04/1985SE |
Questions and answers
When was Apec Glucose Analyzer cleared by the FDA?
Apec Glucose Analyzer (K890524) received a 510(k) decision of Substantially Equivalent on March 15, 1989, 41 days after the submission was received.
What is the product code of K890524?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.