FDA Product Code
FDA Product Code GKF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5600
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) | Instrumentation Laboratory CO | 2016-12-14 | Traditional | PDF ↗ |
| K983551 | CRIT-SCAN II MONITOR | In-Line Diagnostics Corp. | 1999-05-27 | Traditional | PDF ↗ |
| K981425 | STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS | Nova Biomedical Corp. | 1998-05-12 | Traditional | PDF ↗ |
| K981427 | STAT PROFILE M ANALYZER | Nova Biomedical Corp. | 1998-05-12 | Traditional | PDF ↗ |
| K981426 | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS | Nova Biomedical Corp. | 1998-05-12 | Traditional | PDF ↗ |
| K953519 | MICROSPIN 24 | Vulcon Technologies | 1995-11-03 | Traditional | PDF ↗ |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | Fisher Scientific Co., LLC | 1992-03-11 | Traditional | PDF ↗ |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | Fisher Scientific Co., LLC | 1992-01-08 | Traditional | PDF ↗ |
| K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR | Cobe Laboratories, Inc. | 1990-12-27 | Traditional | PDF ↗ |
| K880373 | IONOMETER E-HK AND ACCESSORIES | Smash Ent., Inc. | 1988-03-17 | Traditional | PDF ↗ |
| K870860 | CHEMPRO 1000(TM) | Arden Medical Systems, Inc. | 1987-04-14 | Traditional | PDF ↗ |
| K864646 | SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE | E.I. Dupont DE Nemours & Co., Inc. | 1987-01-05 | Traditional | PDF ↗ |
| K864039 | MICROHEMATOCRIT CENTRIFUGE | Plaza Medical, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K802199 | STAT-CRIT HEMATOCRIT MEASURING INSTRU | United States Surgical, A Division of Tyco Healthc | 1981-02-04 | Traditional | PDF ↗ |
| K781059 | CUTTER/COMPUR MINI CENTRIFUGE | Cutter Laboratories, Inc. | 1978-08-14 | Traditional | PDF ↗ |
Product code GKF · Class II · Hematology. Data: openFDA.