FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTIME MICROCOAGULATION SYSTEM
K Number: K961835
·
Decision Mar 12, 1997
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
47
Review Days
303
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Basic Information
- Device Name
- PROTIME MICROCOAGULATION SYSTEM
- K Number
- K961835
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Technidyne Corp.
- Date Received
- May 13, 1996
- Decision Date
- March 12, 1997
- Product Code
- GJS
- 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 |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
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Other Clearances by International Technidyne Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | Jul 3, 2013 | Substantially Equivalent |
| 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 |