510(k) K880945

CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597 by Lakewood Biochemical Co., Inc. — Product Code JSJ

K880945 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597". The FDA issued a decision of Substantially Equivalent on March 30, 1988. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Lakewood Biochemical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1988
Date Received
March 7, 1988
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