TRIGLYCERIDES (GPO-TRINDER)
FDA 510(k) clearance K880628 · decided 1988-03-15
Clearance details
- K-number
- K880628
- Device name
- TRIGLYCERIDES (GPO-TRINDER)
- Applicant
- Tech-Co, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-02-16
- Decision date
- 1988-03-15
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- CDT
- Device class
- 1
- Regulation number
- 862.1705
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Oak Park, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.