510(k) K894011
K894011 is an FDA 510(k) premarket notification submitted by Alpkem Corp. for the device "TOTAL GALACTOSE". The FDA issued a decision of Substantially Equivalent on January 11, 1990. The device falls under product code KQP (Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase), a Class II device regulated under 21 CFR 862.1315. Alpkem Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1990
- Date Received
- June 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
- Device Class
- Class II
- Regulation Number
- 862.1315
- Review Panel
- CH
- Submission Type