The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for T9802 Tsb W/6.5% Nacl.
Device ID | K870594 |
510k Number | K870594 |
Device Name: | T9802 TSB W/6.5% NACL |
Classification | Culture Media, Selective Broth |
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 | JSD |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-10 |
Decision Date | 1987-03-30 |