Chrono-Log Whole Blood Lumi-Aggregometer, Model 700
FDA 510(k) K050265 · Chrono-Log Corp.
510(k) numberK050265
Submission
- Device name
- Chrono-Log Whole Blood Lumi-Aggregometer, Model 700
- Applicant
- Chrono-Log Corp.
Havertown, PA, US - Received
- February 4, 2005
- Decision date
- October 14, 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
Other 510(k)s with product code JOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K051231 | VERIFYNOW-P2Y12 AssayJOZ · Traditional | Accumetrics, Inc. | 08/05/2005SE |
More from Accumetrics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelJOZ · Special | 12/02/2016SE |
| K032951 | Chrono-Log Whole Blood Aggregometer, Models 591A and 592AJOZ · Traditional | 04/02/2004SE |
| K962426 | Chrono-Log Whole Blood Aggregometer (Wba) 591/592JOZ · Traditional | 10/22/1996SE |
| K945414 | Ristocetin Cofactor Assay KitGGP · Traditional | 01/11/1995SE |
| K940792 | Aggro/Link VW Cofactor SoftwareJOZ · Traditional | 10/13/1994SE |
| K932566 | Aggro/Link Control SoftwareJBX · Traditional | 11/02/1993SE |
| K922800 | Platelet Aggregation ReagentsGHR · Traditional | 08/26/1992SE |
| K851025 | Aggro/Link Computer InterfaceJBX · Traditional | 06/12/1985SE |
| K850592 | Platelet Aggregation ReagentJBX · Traditional | 05/13/1985SE |
| K830749 | Platelet AggregometerJBX · Traditional | 05/16/1983SE |
Questions and answers
When was Chrono-Log Whole Blood Lumi-Aggregometer, Model 700 cleared by the FDA?
Chrono-Log Whole Blood Lumi-Aggregometer, Model 700 (K050265) received a 510(k) decision of Substantially Equivalent on October 14, 2005, 252 days after the submission was received.
What is the product code of K050265?
The FDA product code is JOZ – System, Automated Platelet Aggregation, a Class II (moderate risk) device regulated under 21 CFR 864.5700.