Avl 9181 Electrolyte Analyzer
FDA 510(k) K972673 · Avl Scientific Corp.
510(k) numberK972673
Submission
- Device name
- Avl 9181 Electrolyte Analyzer
- Applicant
- Avl Scientific Corp.
Roswell, GA, US - Received
- July 16, 1997
- Decision date
- August 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFP – Electrode, Ion Specific, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJFP · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFP · Traditional | Abbott Point of Care, Inc. | 02/14/2020SE |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer SystemJFP · Traditional | Nova Biomedical Corporation | 08/16/2019SE |
| K152327 | EasyLyte Na/K/Cl/Ca AnalyzerJFP · Traditional | Medica Corporation | 12/01/2016SE |
| K984299 | Avl Opti Critical Care AnalyzerJFP · Traditional | Avl Scientific Corp. | 12/11/1998SE |
| K963694 | Easylyte Calcium/Chloride AnalyzerJFP · Traditional | Medica Corp. | 11/27/1996SE |
| K961458 | Avl 9180 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 06/12/1996SE |
| K960120 | Stat Profile Ultra F,G,H,I,J, and K AnalyzersJFP · Traditional | Nova Biomedical Corp. | 03/11/1996SE |
| K943091 | Easy Lyte Calcium AnalyzerJFP · Traditional | Medica Corp. | 01/17/1995SE |
| K943702 | Avl 988-4 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 09/09/1994SE |
More from Avl Scientific Corp.
| 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 |
| K972733 | Avl Omni AnalyzerCGA · Traditional | 09/09/1997SE |
| 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 9181 Electrolyte Analyzer cleared by the FDA?
Avl 9181 Electrolyte Analyzer (K972673) received a 510(k) decision of Substantially Equivalent on August 20, 1997, 35 days after the submission was received.
What is the product code of K972673?
The FDA product code is JFP – Electrode, Ion Specific, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.