Crit-Scan II Monitor
FDA 510(k) K983551 · In-Line Diagnostics Corp.
510(k) numberK983551
Submission
- Device name
- Crit-Scan II Monitor
- Applicant
- In-Line Diagnostics Corp.
Farmington, UT, US - Received
- October 9, 1998
- Decision date
- May 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKF – Instrument, Hematocrit, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5600
- Specialty
- Hematology
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|---|---|---|---|
| K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…GKF · Traditional | Instrumentation Laboratory CO | 12/14/2016SE |
| K981427 | Stat Profile M AnalyzerGKF · Traditional | Nova Biomedical Corp. | 05/12/1998SE |
| 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 |
More from Arden Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001763 | Crit-Line Monitor III (CLM III)MQS · Traditional | 12/20/2000SE |
| K992227 | Crit-Line Monitor III (CLM III)MQS · Special | 07/30/1999SE |
| K982412 | Modification of Crit-Line Monitor III (CLM III)MQS · Traditional | 10/09/1998SE |
| K972470 | Crit-Line Monitor (Clmiii)MQS · Traditional | 12/11/1997SE |
| K953875 | Crit-Line Hematocrit Alert (Modification)MQS · Traditional | 07/23/1996SE |
| K950942 | Crit-Line Hematocrit AlertJPI · Traditional | 03/14/1995SE |
| K935958 | Crit-Line Blood Chamber with E-BeamKOC · Traditional | 01/19/1995SE |
Questions and answers
When was Crit-Scan II Monitor cleared by the FDA?
Crit-Scan II Monitor (K983551) received a 510(k) decision of Substantially Equivalent on May 27, 1999, 230 days after the submission was received.
What is the product code of K983551?
The FDA product code is GKF – Instrument, Hematocrit, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5600.