HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
FDA 510(k) clearance K021024 · decided 2002-05-16
Clearance details
- K-number
- K021024
- Device name
- HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2002-03-29
- Decision date
- 2002-05-16
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- GGN
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 recall (Z-0514-2014) | Instrumentation Laboratory Co. | 2013-12-16 |
| HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 recall (Z-0515-2014) | Instrumentation Laboratory Co. | 2013-12-16 |
| HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 recall (Z-0516-2014) | Instrumentation Laboratory Co. | 2013-12-16 |