Dade PFA-100 Platelet Function Analyzer and Reagents
FDA 510(k) K060489 · Dade Behring, Inc.
510(k) numberK060489
Submission
- Device name
- Dade PFA-100 Platelet Function Analyzer and Reagents
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- February 24, 2006
- Decision date
- July 21, 2006
- 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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| 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 |
| 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 |
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Questions and answers
When was Dade PFA-100 Platelet Function Analyzer and Reagents cleared by the FDA?
Dade PFA-100 Platelet Function Analyzer and Reagents (K060489) received a 510(k) decision of Substantially Equivalent on July 21, 2006, 147 days after the submission was received.
What is the product code of K060489?
The FDA product code is JOZ – System, Automated Platelet Aggregation, a Class II (moderate risk) device regulated under 21 CFR 864.5700.