ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
FDA 510(k) clearance K944691 · decided 1995-03-15
Clearance details
- K-number
- K944691
- Device name
- ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-23
- Decision date
- 1995-03-15
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- GGN
- Device class
- 2
- Regulation number
- 864.5425
- 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 |
|---|---|---|
| International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma recall (Z-2200-2010) | International Technidyne Corp. | 2010-08-10 |
| GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061 recall (Z-2107-2010) | International Technidyne Corporation | 2010-07-28 |
| GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. recall (Z-2108-2010) | International Technidyne Corporation | 2010-07-28 |
| directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems. recall (Z-1786-2010) | International Technidyne Corporation | 2010-06-11 |