HDL CHOLESTEROL-E
FDA 510(k) clearance K863065 · decided 1986-09-25
Clearance details
- K-number
- K863065
- Device name
- HDL CHOLESTEROL-E
- Applicant
- J. D. Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-12
- Decision date
- 1986-09-25
- Days to decision
- 44 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Montclair, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.