Nova Stat Profile 7 Analyzer Quality Control Mater
FDA 510(k) K884143 · Nova Biomedical Corp.
510(k) numberK884143
Submission
- Device name
- Nova Stat Profile 7 Analyzer Quality Control Mater
- Applicant
- Nova Biomedical Corp.
Walham, MA, US - Received
- September 30, 1988
- Decision date
- December 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K252207 | ABL90 FLEX PLUS System, safeCLINITUBESCHL · Traditional | Radiometer Medicals Aps | 04/10/2026SE |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K251281 | Nova Max Creat eGFR Monitoring SystemSHB · Traditional | 01/21/2026SE |
| K252206 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | 01/09/2026SE |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP · Dual Track | 11/22/2024SE |
| K221813 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | 11/19/2024SE |
| 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 Nova Stat Profile 7 Analyzer Quality Control Mater cleared by the FDA?
Nova Stat Profile 7 Analyzer Quality Control Mater (K884143) received a 510(k) decision of Substantially Equivalent on December 2, 1988, 63 days after the submission was received.
What is the product code of K884143?
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.