IL TEST ANTITHROMBIN
FDA 510(k) clearance K980499 · decided 1998-04-02
Clearance details
- K-number
- K980499
- Device name
- IL TEST ANTITHROMBIN
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1998-02-09
- Decision date
- 1998-04-02
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- JBQ
- Device class
- 2
- Regulation number
- 864.7060
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.