510(k) K873482

TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033 by Lakewood Biochemical Co., Inc. — Product Code JSG

K873482 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033". The FDA issued a decision of Substantially Equivalent on October 8, 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
October 8, 1987
Date Received
August 27, 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