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510(k) K022086

AIM-V (R) MEDIUM, MODEL 087-0112 by Invitrogen Corporation — Product Code NDS

K022086 is an FDA 510(k) premarket notification submitted by Invitrogen Corporation for the device "AIM-V (R) MEDIUM, MODEL 087-0112". The FDA issued a decision of Substantially Equivalent on December 23, 2002. The device falls under product code NDS (Media, Culture, Ex Vivo, Tissue And Cell), a Class II device regulated under 21 CFR 876.5885.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2002
Date Received
June 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Culture, Ex Vivo, Tissue And Cell
Device Class
Class II
Regulation Number
876.5885
Review Panel
GU
Submission Type

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  • DEN000008 — DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) (February 16, 2001)

FDA data resources