The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Brain Heart Infusion Broth W/6.5% Nac1 - #t3802.
| Device ID | K873218 |
| 510k Number | K873218 |
| Device Name: | BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 |
| Classification | Culture Media, Selective Broth |
| 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 | JSD |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-14 |
| Decision Date | 1987-09-23 |