Aggregrometer, Platelet
FDA product code JBX · Class II (moderate risk) · 21 CFR 864.6675 · Hematology
12510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932566 | Aggro/Link Control SoftwareJBX · Traditional | Chrono-Log Corp. | 11/02/1993SE |
| K912774 | Arachidonic AcidJBX · Traditional | Helena Laboratories | 08/22/1991SE |
| K881829 | Pat Platelet Aggregation TestJBX · Traditional | Streck Laboratories, Inc. | 07/01/1988SE |
| K862775 | Asserachrom B-Tg KitJBX · Traditional | American Bioproducts Co. | 10/22/1986SE |
| K851025 | Aggro/Link Computer InterfaceJBX · Traditional | Chrono-Log Corp. | 06/12/1985SE |
| K850592 | Platelet Aggregation ReagentJBX · Traditional | Chrono-Log Corp. | 05/13/1985SE |
| K832929 | Ristocetin Platelet Aggrega-Reagent TestJBX · Traditional | Sigma Chemical Co. | 09/29/1983SE |
| K830749 | Platelet AggregometerJBX · Traditional | Chrono-Log Corp. | 05/16/1983SE |
| K821005 | Platelet Aggregation Profiler #PAP-4JBX · Traditional | Bio/Data Corp. | 06/01/1982SE |
| K811290 | Arachidonic AcidJBX · Traditional | Bio/Data Corp. | 07/27/1981SE |
| K781710 | Buffer, Collagen Reagent and DiluentJBX · Traditional | Diagnostica, Inc. | 10/24/1978SE |
| K760159 | Aggregometer, Dual Channel PlateletJBX · Traditional | Chrono-Log Corp. | 07/20/1976SE |