510(k) K020490

PBS, PBSW WITH CATIONS AND PHENOL RED by Conception Technologies — Product Code MQL

K020490 is an FDA 510(k) premarket notification submitted by Conception Technologies for the device "PBS, PBSW WITH CATIONS AND PHENOL RED". The FDA issued a decision of Substantially Equivalent on March 28, 2002. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Conception Technologies has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2002
Date Received
February 13, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type