Stat Profile M Analyzer
FDA 510(k) K981427 · Nova Biomedical Corp.
510(k) numberK981427
Submission
- Device name
- Stat Profile M Analyzer
- Applicant
- Nova Biomedical Corp.
Walham, MA, US - Received
- April 16, 1998
- Decision date
- May 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GKF – Instrument, Hematocrit, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5600
- Specialty
- Hematology
Other 510(k)s with product code GKF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…GKF · Traditional | Instrumentation Laboratory CO | 12/14/2016SE |
| K983551 | Crit-Scan II MonitorGKF · Traditional | In-Line Diagnostics Corp. | 05/27/1999SE |
| K981426 | Stat Profile Ultra F,G,H,I,J,K, and L AnalyzersGKF · Traditional | Nova Biomedical Corp. | 05/12/1998SE |
| K981425 | Stat Profile Ultra a, B, C, D, and E AnalyzersGKF · Traditional | Nova Biomedical Corp. | 05/12/1998SE |
| K953519 | Microspin 24GKF · Traditional | Vulcon Technologies | 11/03/1995SE |
| K915825 | Marathon 6K General-Purpose CentrifugeGKF · Traditional | Fisher Scientific Co., LLC | 03/11/1992SE |
| K915441 | Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional | Fisher Scientific Co., LLC | 01/08/1992SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | Cobe Laboratories, Inc. | 12/27/1990SE |
| K880373 | Ionometer E-Hk and AccessoriesGKF · Traditional | Smash Ent., Inc. | 03/17/1988SE |
| K870860 | Chempro 1000(TM)GKF · Traditional | Arden Medical Systems, Inc. | 04/14/1987SE |
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| K251281 | Nova Max Creat eGFR Monitoring SystemSHB · Traditional | 01/21/2026SE |
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| 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 M Analyzer cleared by the FDA?
Stat Profile M Analyzer (K981427) received a 510(k) decision of Substantially Equivalent on May 12, 1998, 26 days after the submission was received.
What is the product code of K981427?
The FDA product code is GKF – Instrument, Hematocrit, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5600.