510(k) K864755

PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM by Gibco Laboratories Life Technologies, Inc. — Product Code JSJ

K864755 is an FDA 510(k) premarket notification submitted by Gibco Laboratories Life Technologies, Inc. for the device "PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM". The FDA issued a decision of Substantially Equivalent on January 5, 1987. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Gibco Laboratories Life Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1987
Date Received
December 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type