510(k) K840105
K840105 is an FDA 510(k) premarket notification submitted by Iso-Tex Diagnostics for the device "APO A-I RIA KIT-HUMAN PLASMA APOLIP-". The FDA issued a decision of SESP on January 10, 1984. Iso-Tex Diagnostics has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESP ()
- Decision Date
- January 10, 1984
- Date Received
- January 10, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No