FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUCLOT CONTROL I, MODEL A4089
K Number: K003328
·
Decision Mar 1, 2001
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
164
Review Days
128
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
- ACCUCLOT CONTROL I, MODEL A4089
- K Number
- K003328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sigma Diagnostics, Inc.
- Date Received
- October 24, 2000
- Decision Date
- March 1, 2001
- Product Code
- GIZ
- 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 |
|---|---|---|---|
| GIZ | Plasma, Control, Normal | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GIZ), ordered by most recent decision date.
STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
FDA 510(k)
FDA Class 2
·Hematology
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
CONTROL PLASMA N
FDA 510(k)
FDA Class 2
·Hematology
REFERENCE CHECK, CATALOG NUMBER-RCN-10
FDA 510(k)
FDA Class 2
·Hematology
CONTROL PLASMA N
FDA 510(k)
FDA Class 2
·Hematology
COAGULATION CONTROL LEVEL 1 (NORMAL)
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Sigma Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021162 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED | Aug 30, 2002 | Substantially Equivalent |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | Feb 6, 2002 | Substantially Equivalent |
| K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 | Dec 26, 2001 | Substantially Equivalent |
| K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | Nov 15, 2001 | Substantially Equivalent |
| K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | Nov 15, 2001 | Substantially Equivalent |
| K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B | Oct 26, 2001 | Substantially Equivalent |
| K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 | Mar 30, 2001 | Substantially Equivalent |
| K010158 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | Mar 22, 2001 | Substantially Equivalent |
| K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | Mar 15, 2001 | Substantially Equivalent |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | Mar 1, 2001 | Substantially Equivalent |