Kit, Platelet Aggregation Reagent (#390)
FDA 510(k) K760198 · Chrono-Log Corp.
510(k) numberK760198
Submission
- Device name
- Kit, Platelet Aggregation Reagent (#390)
- Applicant
- Chrono-Log Corp.
Havertown, PA, US - Received
- July 6, 1976
- Decision date
- July 19, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GHR – Reagent, Platelet Aggregation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5700
- Specialty
- Hematology
Other 510(k)s with product code GHR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061991 | Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional | Helena Laboratories | 02/23/2007SE |
| K952252 | Adp Reagent, ModifiedGHR · Traditional | Helena Laboratories | 09/08/1995SE |
| K922800 | Platelet Aggregation ReagentsGHR · Traditional | Chrono-Log Corp. | 08/26/1992SE |
| K910800 | Adp ReagentGHR · Traditional | Helena Laboratories | 05/20/1991SE |
| K910706 | Collagen Reagent Cat. No. 5368GHR · Traditional | Helena Laboratories | 05/20/1991SE |
| K910680 | Epinephrine Reagent, Cat. No. 5367GHR · Traditional | Helena Laboratories | 05/20/1991SE |
| K910286 | Platelet Aggregation ReagentsGHR · Traditional | Medical Diagnostic Technologies, Inc. | 03/19/1991SE |
| K900792 | RistocetinGHR · Traditional | Medical Diagnostic Technologies, Inc. | 03/27/1990SE |
| K832428 | Platelet Aggregation Reagent SetGHR · Traditional | Helena Laboratories | 10/20/1983SE |
| K820422 | Platelet AggregometersGHR · Traditional | Chrono-Log Corp. | 03/16/1982SE |
More from Chrono-Log Corp.
| 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 |
| K850592 | Platelet Aggregation ReagentJBX · Traditional | 05/13/1985SE |
Questions and answers
When was Kit, Platelet Aggregation Reagent (#390) cleared by the FDA?
Kit, Platelet Aggregation Reagent (#390) (K760198) received a 510(k) decision of Substantially Equivalent on July 19, 1976, 13 days after the submission was received.
What is the product code of K760198?
The FDA product code is GHR – Reagent, Platelet Aggregation, a Class II (moderate risk) device regulated under 21 CFR 864.5700.