510(k) K884649
K884649 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "TOTAL IRON BINDING CAPACITY TEST". The FDA issued a decision of Substantially Equivalent on December 14, 1988. The device falls under product code JQE (Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Sclavo, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 1988
- Date Received
- November 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
- Device Class
- Class I
- Regulation Number
- 862.1415
- Review Panel
- CH
- Submission Type