LITH A TEST TM
FDA 510(k) clearance K830091 · decided 1983-02-15
Clearance details
- K-number
- K830091
- Device name
- LITH A TEST TM
- Applicant
- Lenal Creative Approaches, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-11
- Decision date
- 1983-02-15
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- CEN
- Device class
- 1
- Regulation number
- 862.1550
- 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.