HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
FDA 510(k) clearance K040359 · decided 2004-03-19
Clearance details
- K-number
- K040359
- Device name
- HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2004-02-13
- Decision date
- 2004-03-19
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JPA
- 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
No recalls on record reference this clearance.