The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Tryptic Soy Agar (tsa) W/5% Horse Blood #p2810.
Device ID | K873058 |
510k Number | K873058 |
Device Name: | TRYPTIC SOY AGAR (TSA) W/5% HORSE BLOOD #P2810 |
Classification | Culture Media, Enriched |
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 | KZI |
CFR Regulation Number | 866.2330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-04 |
Decision Date | 1987-08-24 |