FDA 510(k) Applications for Medical Device Product Code "GKF"
(Instrument, Hematocrit, Automated)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K983551 | IN-LINE DIAGNOSTICS CORP. | CRIT-SCAN II MONITOR | 05/27/1999 |
| K160415 | Instrumentation Laboratory Co. | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) | 12/14/2016 |
| K981427 | NOVA BIOMEDICAL CORP. | STAT PROFILE M ANALYZER | 05/12/1998 |
| K981425 | NOVA BIOMEDICAL CORP. | STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS | 05/12/1998 |
| K981426 | NOVA BIOMEDICAL CORP. | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS | 05/12/1998 |
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