510(k) K962843

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

K962843 is an FDA 510(k) premarket notification submitted by Starplex Scientific, Inc. for the device "MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on September 18, 1996. 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
September 18, 1996
Date Received
July 22, 1996
Clearance Type
Traditional
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