The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Brain Heart Infus Agar W/5% Sb & Gentamicin-#p3772.
Device ID | K873224 |
510k Number | K873224 |
Device Name: | BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P3772 |
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 | 1987-08-14 |
Decision Date | 1987-09-23 |