The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Salmonella-shigella (ss) Agar - Product #p3326.
Device ID | K882182 |
510k Number | K882182 |
Device Name: | SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 |
Classification | Culture Media, Selective And 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 | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-24 |
Decision Date | 1988-06-06 |