LEECO TESTO-QUANT DIAGNOSTIC KIT
FDA 510(k) clearance K803001 · decided 1981-01-02
Clearance details
- K-number
- K803001
- Device name
- LEECO TESTO-QUANT DIAGNOSTIC KIT
- Applicant
- Leeco Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-25
- Decision date
- 1981-01-02
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- CDZ
- Device class
- 1
- Regulation number
- 862.1680
- 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.