The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Camplyobacter Culture Media Products P3873/t3597.
| Device ID | K880945 |
| 510k Number | K880945 |
| Device Name: | CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597 |
| Classification | Culture Media, 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 | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-07 |
| Decision Date | 1988-03-30 |