FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASYTOUCH TROMBOPLASTIN REAGENT
K Number: K832427
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
19
Review Days
84
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Basic Information
- Device Name
- EASYTOUCH TROMBOPLASTIN REAGENT
- K Number
- K832427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Worthington Diagnostic Systems
- Date Received
- July 22, 1983
- Decision Date
- October 14, 1983
- Product Code
- GJS
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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 |
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Other Clearances by Worthington Diagnostic Systems
| K Number | Device Name | ||
|---|---|---|---|
| K833708 | COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE | Jan 4, 1984 | Substantially Equivalent |
| K832748 | COMPUR* EASYTOUCH TOTAL BILIRUBIN | Oct 14, 1983 | Substantially Equivalent |
| K832785 | COMPUR* EASY TOUCH URIC ACID REAGENT | Oct 14, 1983 | Substantially Equivalent |
| K832749 | EASYTOUCH BUN REAGENT SET | Oct 14, 1983 | Substantially Equivalent |
| K832750 | EASYTOUCH HEMOGLOBIN REAGENT | Sep 26, 1983 | Substantially Equivalent |
| K832426 | EASYTOUCH TRIGLYCERIDES REAGENT SET | Sep 12, 1983 | Substantially Equivalent |
| K831477 | DEMAND ANALYZER SYSTEM | Jun 17, 1983 | Substantially Equivalent |
| K831318 | COMPUR* M1100 HEMATRCRIT SYSTEM | Jun 8, 1983 | Substantially Equivalent |
| K831227 | COMPUR EASY TOUCH CHEMISTRY ANALYZER- | Jun 2, 1983 | Substantially Equivalent |
| K831102 | TIA-IGA REAGENT & CALIBRATOR SETS | Apr 27, 1983 | Substantially Equivalent |