ALLO-TYPE HUMAN IMMUNOGLOBULIN-
FDA 510(k) clearance K841114 · decided 1984-06-14
Clearance details
- K-number
- K841114
- Device name
- ALLO-TYPE HUMAN IMMUNOGLOBULIN-
- Applicant
- Genetic Testing Institute
- Decision
- Substantially Equivalent
- Date received
- 1984-03-15
- Decision date
- 1984-06-14
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- DGX
- Device class
- 1
- Regulation number
- 866.5065
- 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.