J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.
FDA 510(k) clearance K801662 · decided 1980-09-16
Clearance details
- K-number
- K801662
- Device name
- J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.
- Applicant
- J.T. Baker Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-21
- Decision date
- 1980-09-16
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- DEP
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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.