AC/AD LINEARITY VERIFIERS
FDA 510(k) clearance K982217 · decided 1998-07-02
Clearance details
- K-number
- K982217
- Device name
- AC/AD LINEARITY VERIFIERS
- Applicant
- Sc Calibrators & Controls, LLC
- Decision
- Substantially Equivalent
- Date received
- 1998-06-24
- Decision date
- 1998-07-02
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- DIF
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Santa Monica, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.