Cora (Coagulation Resonance Analysis) System with Platelet Mapping Assay
FDA 510(k) K140893 · Coramed Technologies, LLC
510(k) numberK140893
Submission
- Device name
- Cora (Coagulation Resonance Analysis) System with Platelet Mapping Assay
- Applicant
- Coramed Technologies, LLC
Niles, IL, US - Received
- April 8, 2014
- Decision date
- January 3, 2015
- 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
Other 510(k)s with product code JOZ
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|---|---|---|---|
| K191364 | T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL…JOZ · Traditional | Fujimori Kogyo, Co., Ltd. | 02/14/2020SE |
| K181777 | AggreGuide A-100 ADPJOZ · Traditional | Aggredyne, Inc. | 03/29/2019SE |
| 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 |
| 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 |
| K051231 | VERIFYNOW-P2Y12 AssayJOZ · Traditional | Accumetrics, Inc. | 08/05/2005SE |
More from Accumetrics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150041 | CORA (Coagulation Resonance Analysis) SystemJPA · Traditional | 06/26/2015SE |
Questions and answers
When was Cora (Coagulation Resonance Analysis) System with Platelet Mapping Assay cleared by the FDA?
Cora (Coagulation Resonance Analysis) System with Platelet Mapping Assay (K140893) received a 510(k) decision of Substantially Equivalent on January 3, 2015, 270 days after the submission was received.
What is the product code of K140893?
The FDA product code is JOZ – System, Automated Platelet Aggregation, a Class II (moderate risk) device regulated under 21 CFR 864.5700.