The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Tsa W/neomycin & 5% Sheep Blood - # P3104 & Z3050.
Device ID | K874345 |
510k Number | K874345 |
Device Name: | TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050 |
Classification | Culture Media, Selective And Non-differential |
Applicant | LAKEWOOD BIOCHEMICAL CO., INC. 2111 IRVING BLVD. Dallas, TX 75207 |
Contact | John E Pedigo |
Correspondent | John E Pedigo LAKEWOOD BIOCHEMICAL CO., INC. 2111 IRVING BLVD. Dallas, TX 75207 |
Product Code | JSJ |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-20 |
Decision Date | 1987-11-06 |