510(k) K873704

MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 by Lakewood Biochemical Co., Inc. — Product Code JSH

K873704 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053". The FDA issued a decision of Substantially Equivalent on October 2, 1987. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Lakewood Biochemical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1987
Date Received
September 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type