FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOCHRON RESPONSE/SYSTEM
K Number: K030818
·
Decision Apr 2, 2003
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
47
Review Days
19
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
- HEMOCHRON RESPONSE/SYSTEM
- K Number
- K030818
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Technidyne Corp.
- Date Received
- March 14, 2003
- Decision Date
- April 2, 2003
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JPA), ordered by most recent decision date.
STA Satellite Max®
FDA 510(k)
FDA Class 2
·Hematology
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
FDA 510(k)
FDA Class 2
·Hematology
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
FDA 510(k)
FDA Class 2
·Hematology
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
FDA 510(k)
FDA Class 2
·Hematology
Citrated: K, KH, RTH, FFH
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP 970 CL
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 |
| 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 |