The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Culture Media T2995/2954/2992/2991/2993/2994/2990.
Device ID | K873828 |
510k Number | K873828 |
Device Name: | CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990 |
Classification | Culture Media, Single Biochemical Test |
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 | JSF |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-21 |
Decision Date | 1987-10-06 |