510(k) K864230
K864230 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 28, 1986. The device falls under product code CKE (Acid Phosphatase, Thymolphthale Inmonophosphate), a Class II device regulated under 21 CFR 862.1020. 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
- November 28, 1986
- Date Received
- October 28, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid Phosphatase, Thymolphthale Inmonophosphate
- Device Class
- Class II
- Regulation Number
- 862.1020
- Review Panel
- CH
- Submission Type