Microsample Coagulation Analyzer, Model Mca 310-C
FDA 510(k) K001891 · Bio/Data Corp.
510(k) numberK001891
Submission
- Device name
- Microsample Coagulation Analyzer, Model Mca 310-C
- Applicant
- Bio/Data Corp.
Horsham, PA, US - Received
- June 21, 2000
- Decision date
- July 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKP – Instrument, Coagulation, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Specialty
- Hematology
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| K031377 | Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…GKP · Traditional | Dade Behring, Inc. | 09/08/2003SE |
| K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinGKP · Traditional | Fisher Diagnostics | 12/09/2002SE |
More from Fisher Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K943153 | Microsample Coagulation AnalyzerGKP · Traditional | 03/24/1995SE |
| K893650 | Platelet Aggregation Profiler Model PAP-4CJPA · Traditional | 06/23/1989SE |
| K881150 | Kinetic Fibrinogen AssayGIS · Traditional | 03/28/1988SE |
| K873382 | Platelet Extract ReagentGGW · Traditional | 11/20/1987SE |
| K860751 | Von Willebrand Fac. Defic. Abnormal Control PlasmaJPK · Traditional | 03/18/1986SE |
| K860342 | Microsample Coagulation Analyser, Model 110WPJPA · Traditional | 03/04/1986SE |
| K854546 | Microsample Coagulation Analyser Model 110PJPA · Traditional | 01/07/1986SE |
| K853897 | Citrex HGGW · Traditional | 10/10/1985SE |
| K853246 | Calcium ChlorideJPA · Traditional | 08/13/1985SE |
| K853078 | Citrex IIIJPA · Traditional | 08/12/1985SE |
Questions and answers
When was Microsample Coagulation Analyzer, Model Mca 310-C cleared by the FDA?
Microsample Coagulation Analyzer, Model Mca 310-C (K001891) received a 510(k) decision of Substantially Equivalent on July 12, 2000, 21 days after the submission was received.
What is the product code of K001891?
The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.