FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STA-QUALITY HBPM/LMWH KIT
K Number: K010324
·
Decision Apr 9, 2001
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
16
Review Days
66
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
- STA-QUALITY HBPM/LMWH KIT
- K Number
- K010324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostica Stago, Inc.
- Date Received
- February 2, 2001
- Decision Date
- April 9, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GGN), ordered by most recent decision date.
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
FDA 510(k)
FDA Class 2
·Hematology
VALIDATE Heparin Calibration Verification/Linearity Test Kit
FDA 510(k)
FDA Class 2
·Hematology
George King Coumadin Plasma
FDA 510(k)
FDA Class 2
·Hematology
VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
FDA 510(k)
FDA Class 2
·Hematology
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
FDA 510(k)
FDA Class 2
·Hematology
VisuCon-F Low Fibrinogen Control Plasma
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Diagnostica Stago, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253658 | STA Satellite Max® | Apr 27, 2026 | Substantially Equivalent |
| K120014 | STA- COAG CONTROL (N+ABN) PLUS | Mar 14, 2013 | Substantially Equivalent |
| K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | Oct 26, 2011 | Substantially Equivalent |
| K092937 | STA-HYBRID HEP CALIBRATOR | Aug 2, 2010 | Substantially Equivalent |
| K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | Dec 22, 2009 | Substantially Equivalent |
| K092170 | STA LIATEST FREE PS | Dec 22, 2009 | Substantially Equivalent |
| K092113 | STA - FREE PS CALIBRATOR | Nov 13, 2009 | Substantially Equivalent |
| K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER | Dec 12, 2008 | Substantially Equivalent |
| K082675 | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER | Oct 10, 2008 | Substantially Equivalent |
| K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | Dec 6, 2006 | Substantially Equivalent |