Dade PFA-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/
FDA 510(k) K970505 · Dade Intl., Inc.
510(k) numberK970505
Submission
- Device name
- Dade PFA-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/
- Applicant
- Dade Intl., Inc.
Miami, FL, US - Received
- February 10, 1997
- Decision date
- November 17, 1997
- 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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|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K974343 | Dade InnovinGJS · Traditional | 07/22/1998SE |
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| K973668 | Cardiac Troponin-I (Trop) CalibratorJIT · Traditional | 10/20/1997SE |
| K972524 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 09/08/1997SE |
| K972782 | Dade Stratus Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 08/15/1997SE |
| K972287 | Dade Tru-Liquid Bilirubin ControlJJX · Traditional | 07/07/1997SE |
| K964660 | Paramax Cholesterol ReagentCHH · Traditional | 06/04/1997SE |
| K970676 | Dried Gram-Negative Mic/Combo PanelsJWY · Traditional | 05/02/1997SE |
| K964715 | Paramax Salicylate ReagentDKJ · Traditional | 04/25/1997SE |
| K970330 | Dade Indirect Imt System with TCO2 ElectrodeCEM · Traditional | 04/14/1997SE |
Questions and answers
When was Dade PFA-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/ cleared by the FDA?
Dade PFA-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/ (K970505) received a 510(k) decision of Substantially Equivalent on November 17, 1997, 280 days after the submission was received.
What is the product code of K970505?
The FDA product code is JOZ – System, Automated Platelet Aggregation, a Class II (moderate risk) device regulated under 21 CFR 864.5700.