510(k) K032246

MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM by Starplex Scientific, Inc. — Product Code JSM

K032246 is an FDA 510(k) premarket notification submitted by Starplex Scientific, Inc. for the device "MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 13, 2003. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Starplex Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2003
Date Received
July 22, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type