510(k) K874538

TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516 by Lakewood Biochemical Co., Inc. — Product Code JSG

K874538 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516". The FDA issued a decision of Substantially Equivalent on November 20, 1987. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Lakewood Biochemical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1987
Date Received
November 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type