FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOSIL PROS
K Number: K053499
·
Decision Jan 13, 2006
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
188
Applicant Total
300
Review Days
28
Basic Information
- Device Name
- HEMOSIL PROS
- K Number
- K053499
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INSTRUMENTATION LABORATORY CO.
- Date Received
- December 16, 2005
- Decision Date
- January 13, 2006
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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Other Clearances by INSTRUMENTATION LABORATORY CO.
| K Number | Device Name | ||
|---|---|---|---|
| K170314 | ACL AcuStar | Mar 3, 2017 | Substantially Equivalent |
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| K160885 | HemosIL D-Dimer HS | Oct 27, 2016 | Substantially Equivalent |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | Jul 8, 2016 | Substantially Equivalent |
| K160445 | HemosIL Silica Clotting Time | Mar 16, 2016 | Substantially Equivalent |
| K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) | Mar 3, 2016 | Substantially Equivalent |
| K151534 | HemosIL D-Dimer HS | Jul 6, 2015 | Substantially Equivalent |
| K133005 | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY | Mar 13, 2014 | Substantially Equivalent |
| K132722 | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) | Jan 22, 2014 | Substantially Equivalent |
| K133407 | GEM PREMIER 4000 | Jan 13, 2014 | Substantially Equivalent |