Nova 2 Ionized Calcium Analyzer
FDA 510(k) K771643 · Nova Biomedical Corp.
510(k) numberK771643
Submission
- Device name
- Nova 2 Ionized Calcium Analyzer
- Applicant
- Nova Biomedical Corp.
Mchenry, IL, US - Received
- August 29, 1977
- Decision date
- September 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K972673 | Avl 9181 Electrolyte AnalyzerJFP · Traditional | Avl Scientific Corp. | 08/20/1997SE |
| 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 |
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Questions and answers
When was Nova 2 Ionized Calcium Analyzer cleared by the FDA?
Nova 2 Ionized Calcium Analyzer (K771643) received a 510(k) decision of Substantially Equivalent on September 28, 1977, 30 days after the submission was received.
What is the product code of K771643?
The FDA product code is JFP – Electrode, Ion Specific, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.