510(k) K871324

DU PONT STERICELL CELL CULTURE SYSTEM by E.I. Dupont DE Nemours & Co., Inc. — Product Code KJA

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