FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
K Number: K010599
·
Decision Jul 2, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
47
Review Days
124
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
- K Number
- K010599
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Technidyne Corp.
- Date Received
- February 28, 2001
- Decision Date
- July 2, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GJS), ordered by most recent decision date.
CoaguChek XS Plus System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
Xprecia Prime Coagulation System
FDA 510(k)
FDA Class 2
·Hematology
i-STAT PTplus Cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
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 |
| 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 |