The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Tryptic Soy Agar (tsa - Product #p2802).
Device ID | K873053 |
510k Number | K873053 |
Device Name: | TRYPTIC SOY AGAR (TSA - PRODUCT #P2802) |
Classification | Culture Media, Non-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 | JSG |
CFR Regulation Number | 866.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-04 |
Decision Date | 1987-08-24 |