Stat Profile Ultra L Analyzer Quality Control Materials
FDA 510(k) K961938 · Nova Biomedical Corp.
510(k) numberK961938
Submission
- Device name
- Stat Profile Ultra L Analyzer Quality Control Materials
- Applicant
- Nova Biomedical Corp.
Walham, MA, US - Received
- May 20, 1996
- Decision date
- June 28, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GJS – Test, Time, Prothrombin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7750
- Specialty
- Hematology
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| K253188 | CoaguChek XS Plus SystemGJS · Special | Roche Diagnostics | 10/24/2025SE |
| K251564 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 07/21/2025SE |
| K243543 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 02/27/2025SE |
| K230802 | Xprecia Prime Coagulation SystemGJS · Dual Track | Universal Biosensors Pty, Ltd. | 03/15/2024SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | Abbott Laboratories | 07/14/2023SE |
| K231711 | microINR SystemGJS · Special | Iline Microsystems, S.L. | 07/11/2023SE |
| K211485 | STA- NeoPTimalGJS · Traditional | Diagnostica Stago S.A.S | 12/23/2022SE |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingGJS · Special | Coagusense, Inc. | 10/05/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | Instrumentation Laboratory CO | 08/16/2022SE |
| K201185 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 12/18/2020SE |
More from Iline Microsystems, S.L.
| 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 Stat Profile Ultra L Analyzer Quality Control Materials cleared by the FDA?
Stat Profile Ultra L Analyzer Quality Control Materials (K961938) received a 510(k) decision of Substantially Equivalent on June 28, 1996, 39 days after the submission was received.
What is the product code of K961938?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.