510(k) K812081
K812081 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO NEFA C TEST". The FDA issued a decision of Substantially Equivalent on August 12, 1981. The device falls under product code JLG (Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids), a Class I device regulated under 21 CFR 862.1290. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1981
- Date Received
- July 22, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
- Device Class
- Class I
- Regulation Number
- 862.1290
- Review Panel
- CH
- Submission Type