The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Sabouraud Dextrose - Emmons Agar Plate #p3252.
Device ID | K873328 |
510k Number | K873328 |
Device Name: | SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252 |
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 | 1987-08-18 |
Decision Date | 1987-10-02 |