KOVA TROL III
FDA 510(k) clearance K780482 · decided 1978-05-03
Clearance details
- K-number
- K780482
- Device name
- KOVA TROL III
- Applicant
- Icl Scientific
- Decision
- Substantially Equivalent
- Date received
- 1978-03-27
- Decision date
- 1978-05-03
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- JJW
- Device class
- 1
- Regulation number
- 862.1660
- 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.