510(k) K873411

SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084 by Lakewood Biochemical Co., Inc. — Product Code JSH

K873411 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084". The FDA issued a decision of Substantially Equivalent on October 6, 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 6, 1987
Date Received
August 24, 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