510(k) K871324
K871324 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT STERICELL CELL CULTURE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 14, 1987. The device falls under product code KJA (Flask, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. 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
- April 14, 1987
- Date Received
- April 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flask, Tissue Culture
- Device Class
- Class I
- Regulation Number
- 864.2240
- Review Panel
- PA
- Submission Type