Platelet Aggregation Reagents
FDA 510(k) K910286 · Medical Diagnostic Technologies, Inc.
510(k) numberK910286
Submission
- Device name
- Platelet Aggregation Reagents
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- January 22, 1991
- Decision date
- March 19, 1991
- 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 |
| 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 |
| K760198 | Kit, Platelet Aggregation Reagent (#390)GHR · Traditional | Chrono-Log Corp. | 07/19/1976SE |
More from Chrono-Log Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K062229 | CTC Workstation, Model 2200LLZ · Traditional | 09/11/2006SE |
| K972209 | Spectrolyse Heparin (Anti-Iia)KFF · Traditional | 08/12/1997SE |
| K963106 | Chromolize PAI-1 KitGGP · Traditional | 11/18/1996SE |
| K960871 | Spectrolyse Antithrombin III (Anti-Xa)JBQ · Traditional | 08/14/1996SE |
| K962489 | Chromolize Tpa Assay KitGGP · Traditional | 07/31/1996SE |
| K960438 | Tintelize PAI-1 KitGGP · Traditional | 06/05/1996SE |
| K961724 | U-Doa ControlsDIF · Traditional | 06/03/1996SE |
| K961370 | La Positive Control PlasmaGGC · Traditional | 05/24/1996SE |
| K955115 | Venom Tiem ReagentJCO · Traditional | 04/03/1996SE |
| K955738 | Bioclot Protein SGGP · Traditional | 02/29/1996SE |
Questions and answers
When was Platelet Aggregation Reagents cleared by the FDA?
Platelet Aggregation Reagents (K910286) received a 510(k) decision of Substantially Equivalent on March 19, 1991, 56 days after the submission was received.
What is the product code of K910286?
The FDA product code is GHR – Reagent, Platelet Aggregation, a Class II (moderate risk) device regulated under 21 CFR 864.5700.