The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for P1012 Be Agar.
Device ID | K870341 |
510k Number | K870341 |
Device Name: | P1012 BE AGAR |
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 | 1987-01-28 |
Decision Date | 1987-02-13 |