510(k) K813366
K813366 is an FDA 510(k) premarket notification submitted by Wako Pure Chemical Industries, Ltd. for the device "AMMONIA TEST". The FDA issued a decision of Substantially Equivalent on December 22, 1981. The device falls under product code JID (Photometric Method, Ammonia), a Class I device regulated under 21 CFR 862.1065. Wako Pure Chemical Industries, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1981
- Date Received
- November 30, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photometric Method, Ammonia
- Device Class
- Class I
- Regulation Number
- 862.1065
- Review Panel
- CH
- Submission Type