GKF — Instrument, Hematocrit, Automated Class II
FDA product code GKF covers "Instrument, Hematocrit, Automated", a Class II medical device regulated under 21 CFR 864.5600. Submissions are reviewed by the Hematology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKF
- Device Class
- Class II
- Regulation Number
- 864.5600
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K160415 | instrumentation laboratory | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemo | December 14, 2016 |
| K983551 | in-line diagnostics | CRIT-SCAN II MONITOR | May 27, 1999 |
| K981427 | nova biomedical | STAT PROFILE M ANALYZER | May 12, 1998 |
| K981426 | nova biomedical | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS | May 12, 1998 |
| K981425 | nova biomedical | STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS | May 12, 1998 |
| K953519 | vulcon technologies | MICROSPIN 24 | November 3, 1995 |
| K915825 | fisher scientific co | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | March 11, 1992 |
| K915441 | fisher scientific co | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | January 8, 1992 |
| K904336 | cobe laboratories | NEW COBE SATURATION/HEMATOCRIT MONITOR | December 27, 1990 |
| K880373 | smash ent | IONOMETER E-HK AND ACCESSORIES | March 17, 1988 |
| K870860 | arden medical systems | CHEMPRO 1000(TM) | April 14, 1987 |
| K864646 | e.i. dupont de nemours and co | SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE | January 5, 1987 |
| K864039 | plaza medical | MICROHEMATOCRIT CENTRIFUGE | October 29, 1986 |
| K802199 | united states surgical, a division of tyco healthc | STAT-CRIT HEMATOCRIT MEASURING INSTRU | February 4, 1981 |
| K781059 | cutter laboratories | CUTTER/COMPUR MINI CENTRIFUGE | August 14, 1978 |