510(k) K873061

TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T1405 by Lakewood Biochemical Co., Inc. — Product Code KZI

K873061 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T1405". The FDA issued a decision of Substantially Equivalent on August 24, 1987. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. Lakewood Biochemical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1987
Date Received
August 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Enriched
Device Class
Class I
Regulation Number
866.2330
Review Panel
MI
Submission Type