APO-TEK LP(A)
FDA 510(k) clearance K970302 · decided 1997-11-10
Clearance details
- K-number
- K970302
- Device name
- APO-TEK LP(A)
- Applicant
- Perimmune, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-27
- Decision date
- 1997-11-10
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- DFC
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.