510(k) K873952

MICRO CULTURE MEDIA P3141, P3136, P3148, P3748 by Lakewood Biochemical Co., Inc. — Product Code KZI

K873952 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "MICRO CULTURE MEDIA P3141, P3136, P3148, P3748". The FDA issued a decision of Substantially Equivalent on October 23, 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
October 23, 1987
Date Received
September 28, 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