FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
K Number: K120977
·
Decision Jul 3, 2013
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
47
Review Days
457
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Basic Information
- Device Name
- DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
- K Number
- K120977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Technidyne Corp.
- Date Received
- April 2, 2012
- Decision Date
- July 3, 2013
- Product Code
- GGN
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | FDA class 2 | Hematology |
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Other Clearances by International Technidyne Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K050016 | HEMOCHRON SIGNATURE ELITE | Feb 10, 2005 | Substantially Equivalent |
| K030818 | HEMOCHRON RESPONSE/SYSTEM | Apr 2, 2003 | Substantially Equivalent |
| K023561 | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM | Jan 31, 2003 | Substantially Equivalent |
| K020798 | HEMOCHRON JR. SIGNATURE + | Mar 28, 2002 | Substantially Equivalent |
| K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE | Jul 2, 2001 | Substantially Equivalent |
| K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | Jun 6, 2001 | Substantially Equivalent |
| K983475 | HEMOCHRON RESPONSE | May 3, 1999 | Substantially Equivalent |
| K990449 | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE | Apr 13, 1999 | Substantially Equivalent |
| K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT | Sep 30, 1998 | Substantially Equivalent |
| K974799 | HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE | Jul 7, 1998 | Substantially Equivalent |