The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Todd-hewitt Broth (0.5ml)#3099 & (5.oml)#t3516.
| Device ID | K874538 |
| 510k Number | K874538 |
| Device Name: | TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516 |
| Classification | Culture Media, Non-selective And Non-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 | JSG |
| CFR Regulation Number | 866.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-03 |
| Decision Date | 1987-11-20 |