510(k) K801076
K801076 is an FDA 510(k) premarket notification submitted by Wako Pure Chemical Industries, Ltd. for the device "WAKO PHOSPHOLIPIDS TEST". The FDA issued a decision of Substantially Equivalent on June 30, 1980. The device falls under product code CEL (Ammonium Molybdate And Ammonium Vanadate, Phospholipids), a Class I device regulated under 21 CFR 862.1575. Wako Pure Chemical Industries, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1980
- Date Received
- May 7, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ammonium Molybdate And Ammonium Vanadate, Phospholipids
- Device Class
- Class I
- Regulation Number
- 862.1575
- Review Panel
- CH
- Submission Type