510(k) K890721
K890721 is an FDA 510(k) premarket notification submitted by Actio, Inc. for the device "SHAPE-ACTIO METAL TOXICOLOGY CONTROL". The FDA issued a decision of Substantially Equivalent on April 10, 1989. The device falls under product code DIE (Heavy Metals Control Materials), a Class I device regulated under 21 CFR 862.3280. Actio, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1989
- Date Received
- February 13, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heavy Metals Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type