The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Legionella Cye Agar Base & Bcye Suppl.
| Device ID | K831469 |
| 510k Number | K831469 |
| Device Name: | LEGIONELLA CYE AGAR BASE & BCYE SUPPL |
| Classification | Supplement, Culture Media |
| Applicant | OXOID U.S.A., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JSK |
| CFR Regulation Number | 866.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-06 |
| Decision Date | 1983-06-08 |