PLAN A LIFE
FDA 510(k) clearance K830975 · decided 1983-05-04
Clearance details
- K-number
- K830975
- Device name
- PLAN A LIFE
- Applicant
- New Directions Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-25
- Decision date
- 1983-05-04
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- JIN
- Device class
- 1
- Regulation number
- 862.1435
- 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.