VERIFYNOW-P2Y12 Assay
FDA 510(k) K051231 · Accumetrics, Inc.
510(k) numberK051231
Submission
- Device name
- VERIFYNOW-P2Y12 Assay
- Applicant
- Accumetrics, Inc.
San Diego, CA, US - Received
- May 13, 2005
- Decision date
- August 5, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOZ – System, Automated Platelet Aggregation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5700
- Specialty
- Hematology
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| K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentJOZ · Special | Aggredyne, Inc. | 04/05/2017SE |
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelJOZ · Special | Chrono-Log Corp. | 12/02/2016SE |
| K141427 | Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestJOZ · Traditional | Accumetrics, Inc. | 07/24/2015SE |
| K140893 | Cora (Coagulation Resonance Analysis) System with Platelet Mapping AssayJOZ · Traditional | Coramed Technologies, LLC | 01/03/2015SE |
| K122162 | AggreguideJOZ · Traditional | Aggredyne, Inc. | 12/20/2013SE |
| K103555 | Multiplate 5.0 AggregometerJOZ · Traditional | Verum Diagnostica GmbH | 07/27/2012SE |
| K060489 | Dade PFA-100 Platelet Function Analyzer and ReagentsJOZ · Traditional | Dade Behring, Inc. | 07/21/2006SE |
| K050265 | Chrono-Log Whole Blood Lumi-Aggregometer, Model 700JOZ · Traditional | Chrono-Log Corp. | 10/14/2005SE |
More from Chrono-Log Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K141427 | Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestJOZ · Traditional | 07/24/2015SE |
| K042423 | Verifynow-Aspirin AssayJOZ · Special | 10/06/2004SE |
| K012701 | Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)JOZ · Traditional | 06/12/2002SE |
| K013596 | Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap)JOZ · Traditional | 05/16/2002SE |
| K011337 | Ultegra System Rapid Platelet Function Assay (Rpfa)JOZ · Traditional | 10/16/2001SE |
| K992531 | Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra System…JOZ · Traditional | 12/20/1999SE |
Questions and answers
When was VERIFYNOW-P2Y12 Assay cleared by the FDA?
VERIFYNOW-P2Y12 Assay (K051231) received a 510(k) decision of Substantially Equivalent on August 5, 2005, 84 days after the submission was received.
What is the product code of K051231?
The FDA product code is JOZ – System, Automated Platelet Aggregation, a Class II (moderate risk) device regulated under 21 CFR 864.5700.