Avl Opti R Analyzer
FDA 510(k) K000103 · Avl Scientific Corp.
510(k) numberK000103
Submission
- Device name
- Avl Opti R Analyzer
- Applicant
- Avl Scientific Corp.
Roswell, GA, US - Received
- January 13, 2000
- Decision date
- March 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 05/02/2025SE |
| K240998 | ABL90 FLEX PLUS SystemCHL · Traditional | Radiometer Medicals Aps | 12/13/2024SE |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | Nova Biomedical Corporation | 09/29/2023SE |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 09/15/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | Instrumentation Laboratory Company | 08/10/2023SE |
| K211559 | EasyStat 300CHL · Traditional | Medica Corporation | 01/27/2023SE |
| K203790 | GEM Premier 5000CHL · Special | Instrumentation Laboratory CO | 08/20/2021SE |
| K200986 | OPTI® B-Lac CassetteCHL · Traditional | Opti Medical Systems, Inc. | 08/02/2021SE |
More from Opti Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001632 | Opti-Check Plus Multi-Analyte Control, Model HC7009JJY · Traditional | 06/19/2000SE |
| 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 |
| K972733 | Avl Omni AnalyzerCGA · Traditional | 09/09/1997SE |
| 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 Opti R Analyzer cleared by the FDA?
Avl Opti R Analyzer (K000103) received a 510(k) decision of Substantially Equivalent on March 20, 2000, 67 days after the submission was received.
What is the product code of K000103?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.