The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Motility Indole Ornathine (mio) Product #t3053.
| Device ID | K873704 |
| 510k Number | K873704 |
| Device Name: | MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 |
| Classification | Culture Media, Non-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 | JSH |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-14 |
| Decision Date | 1987-10-02 |