510(k) K810951
K810951 is an FDA 510(k) premarket notification submitted by Mid Tech, Inc. for the device "REAGENTS FOR QUANT. ENZYMATIC DETER.-TR.". The FDA issued a decision of Substantially Equivalent on April 23, 1981. Mid Tech, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1981
- Date Received
- April 7, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No