TRIGLYCERIDE CALIBRATORS
FDA 510(k) clearance K813478 · decided 1981-12-22
Clearance details
- K-number
- K813478
- Device name
- TRIGLYCERIDE CALIBRATORS
- Applicant
- Gilford Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1981-12-01
- Decision date
- 1981-12-22
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- JIS
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.