Chempro 1000(TM)
FDA 510(k) K870860 · Arden Medical Systems, Inc.
510(k) numberK870860
Submission
- Device name
- Chempro 1000(TM)
- Applicant
- Arden Medical Systems, Inc.
Arden Hills, MN, US - Received
- March 3, 1987
- Decision date
- April 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Smash Ent., Inc.
Questions and answers
When was Chempro 1000(TM) cleared by the FDA?
Chempro 1000(TM) (K870860) received a 510(k) decision of Substantially Equivalent on April 14, 1987, 42 days after the submission was received.
What is the product code of K870860?
The FDA product code is GKF – Instrument, Hematocrit, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5600.