510(k) K842019
K842019 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "TIBC PRETREATMENT KIT". The FDA issued a decision of Substantially Equivalent on June 22, 1984. 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. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1984
- Date Received
- May 18, 1984
- 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