The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Sabour Dextrose/bhi Sd/bhi Agar Slt Tube #t4300.
Device ID | K873321 |
510k Number | K873321 |
Device Name: | SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300 |
Classification | Culture Media, Enriched |
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 | KZI |
CFR Regulation Number | 866.2330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-18 |
Decision Date | 1987-09-29 |