PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
FDA 510(k) clearance K010599 · decided 2001-07-02
Clearance details
- K-number
- K010599
- Device name
- PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-28
- Decision date
- 2001-07-02
- Days to decision
- 124 days
- Clearance type
- Special
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouc recall (Z-2198-2013) | Assuramed | 2013-09-13 |
| Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. Intern recall (Z-0837-2013) | International Technidyne Corp. | 2013-02-19 |
| ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Te recall (Z-0546-2008) | International Technidyne Corporation | 2008-01-25 |