ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN
FDA 510(k) clearance K790710 · decided 1979-08-03
Clearance details
- K-number
- K790710
- Device name
- ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN
- Applicant
- Kent Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-04-12
- Decision date
- 1979-08-03
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- DDY
- Device class
- 2
- Regulation number
- 866.5620
- 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.