The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Hektoen Enteric (he) Agar Product #p3330.
| Device ID | K873329 |
| 510k Number | K873329 |
| Device Name: | HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330 |
| Classification | Culture Media, 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 | JSI |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-20 |
| Decision Date | 1987-10-02 |