510(k) K873218

BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 by Lakewood Biochemical Co., Inc. — Product Code JSD

K873218 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802". The FDA issued a decision of Substantially Equivalent on September 23, 1987. The device falls under product code JSD (Culture Media, Selective Broth), 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
September 23, 1987
Date Received
August 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective Broth
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type