The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Mueller Hinton Agar Plates P3318/1&2/p3418/p34181.
| Device ID | K882351 |
| 510k Number | K882351 |
| Device Name: | MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/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 | JTZ |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-07 |
| Decision Date | 1988-06-28 |