Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
FDA 510(k) K142220 · Nova Biomedical Corporation
510(k) numberK142220
Submission
- Device name
- Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
- Applicant
- Nova Biomedical Corporation
Walham, MA, US - Received
- August 12, 2014
- Decision date
- October 17, 2014
- 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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| 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 |
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| K232075 | StatStrip Glucose Hospital Meter SystemPZI · Dual Track | 02/23/2024SE |
| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | 09/29/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | 10/18/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | 04/14/2020SE |
| K200204 | Stat Profile Prime Plus Analyzer SystemGGZ · Traditional | 04/06/2020SE |
| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | 03/13/2020SE |
Questions and answers
When was Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) cleared by the FDA?
Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) (K142220) received a 510(k) decision of Substantially Equivalent on October 17, 2014, 66 days after the submission was received.
What is the product code of K142220?
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.