Avl Omni Analyzer
FDA 510(k) K972733 · Avl Scientific Corp.
510(k) numberK972733
Submission
- Device name
- Avl Omni Analyzer
- Applicant
- Avl Scientific Corp.
Roswell, GA, US - Received
- July 21, 1997
- Decision date
- September 9, 1997
- 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
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More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K001632 | Opti-Check Plus Multi-Analyte Control, Model HC7009JJY · Traditional | 06/19/2000SE |
| K000103 | Avl Opti R AnalyzerCHL · Traditional | 03/20/2000SE |
| K993837 | Avl Opti Critical Care AnalyzerCGA · Traditional | 12/16/1999SE |
| K990092 | Avl Omni Modular AnalyzerCHL · Traditional | 01/29/1999SE |
| K984299 | Avl Opti Critical Care AnalyzerJFP · Traditional | 12/11/1998SE |
| K974784 | Avl Opti Critical Care AnalyzerCEM · Traditional | 02/24/1998SE |
| K974822 | Avl Opti-Check Ph/ Blood Gas/ Electrolyte/Thb/ SO2 ControlJJY · Traditional | 01/22/1998SE |
| K972673 | Avl 9181 Electrolyte AnalyzerJFP · Traditional | 08/20/1997SE |
| K963964 | Avl Compact 3 Ph/Blood Gas AnalyzerCHL · Traditional | 11/29/1996SE |
| K961458 | Avl 9180 Electrolyte AnalyzerJFP · Traditional | 06/12/1996SE |
Questions and answers
When was Avl Omni Analyzer cleared by the FDA?
Avl Omni Analyzer (K972733) received a 510(k) decision of Substantially Equivalent on September 9, 1997, 50 days after the submission was received.
What is the product code of K972733?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.