Asserachrom B-Tg Kit
FDA 510(k) K862775 · American Bioproducts Co.
510(k) numberK862775
Submission
- Device name
- Asserachrom B-Tg Kit
- Applicant
- American Bioproducts Co.
Parsippany, NJ, US - Received
- July 22, 1986
- Decision date
- October 22, 1986
- 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 |
| 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 |
More from Diagnostica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983460 | Star Automated Multi-Parametric AnalyzerJPA · Traditional | 11/12/1998SE |
| K971519 | Asserachrom Tpa Test KitGGP · Traditional | 08/19/1997SE |
| K964728 | Sta-Liatest D-Di Test KitDAP · Traditional | 06/26/1997SE |
| K964716 | Sta Liatest Control [N]+[P] KitGGN · Traditional | 06/26/1997SE |
| K964718 | Sta D-Di Calibrator KitDAP · Traditional | 05/23/1997SE |
| K962675 | Sta - Liatest VWF Test KitGJT · Traditional | 10/25/1996SE |
| K962671 | Sta-Vwf Calibrator KitGJT · Traditional | 09/13/1996SE |
| K962674 | Sta - VWF Control [N]+[P] KitGGN · Traditional | 07/23/1996SE |
| K961579 | Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional | 07/10/1996SE |
| K955040 | At-Iii Control Plasma KitGGC · Traditional | 01/31/1996SE |
Questions and answers
When was Asserachrom B-Tg Kit cleared by the FDA?
Asserachrom B-Tg Kit (K862775) received a 510(k) decision of Substantially Equivalent on October 22, 1986, 92 days after the submission was received.
What is the product code of K862775?
The FDA product code is JBX – Aggregrometer, Platelet, a Class II (moderate risk) device regulated under 21 CFR 864.6675.