Platelet Aggregation Reagent
FDA 510(k) K850592 · Chrono-Log Corp.
510(k) numberK850592
Submission
- Device name
- Platelet Aggregation Reagent
- Applicant
- Chrono-Log Corp.
Havertown, PA, US - Received
- February 15, 1985
- Decision date
- May 13, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JBX – Aggregrometer, Platelet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6675
- Specialty
- Hematology
Other 510(k)s with product code JBX
| 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 |
| 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 |
More from Diagnostica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelJOZ · Special | 12/02/2016SE |
| K050265 | Chrono-Log Whole Blood Lumi-Aggregometer, Model 700JOZ · Traditional | 10/14/2005SE |
| K032951 | Chrono-Log Whole Blood Aggregometer, Models 591A and 592AJOZ · Traditional | 04/02/2004SE |
| K962426 | Chrono-Log Whole Blood Aggregometer (Wba) 591/592JOZ · Traditional | 10/22/1996SE |
| K945414 | Ristocetin Cofactor Assay KitGGP · Traditional | 01/11/1995SE |
| K940792 | Aggro/Link VW Cofactor SoftwareJOZ · Traditional | 10/13/1994SE |
| K932566 | Aggro/Link Control SoftwareJBX · Traditional | 11/02/1993SE |
| K922800 | Platelet Aggregation ReagentsGHR · Traditional | 08/26/1992SE |
| K851025 | Aggro/Link Computer InterfaceJBX · Traditional | 06/12/1985SE |
| K830749 | Platelet AggregometerJBX · Traditional | 05/16/1983SE |
Questions and answers
When was Platelet Aggregation Reagent cleared by the FDA?
Platelet Aggregation Reagent (K850592) received a 510(k) decision of Substantially Equivalent on May 13, 1985, 87 days after the submission was received.
What is the product code of K850592?
The FDA product code is JBX – Aggregrometer, Platelet, a Class II (moderate risk) device regulated under 21 CFR 864.6675.