510(k) K841114
K841114 is an FDA 510(k) premarket notification submitted by Genetic Testing Institute for the device "ALLO-TYPE HUMAN IMMUNOGLOBULIN-". The FDA issued a decision of Substantially Equivalent on June 14, 1984. The device falls under product code DGX (Ng1m(A), Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5065. Genetic Testing Institute has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1984
- Date Received
- March 15, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ng1m(A), Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5065
- Review Panel
- IM
- Submission Type