CARESIDE GLOBULIN
FDA 510(k) clearance K980055 · decided 1998-01-28
Clearance details
- K-number
- K980055
- Device name
- CARESIDE GLOBULIN
- Applicant
- Exigent Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-06
- Decision date
- 1998-01-28
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- JGE
- Device class
- 1
- Regulation number
- 862.1330
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.