The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Synthetic Broth A.o.a.c..
| Device ID | K841661 |
| 510k Number | K841661 |
| Device Name: | SYNTHETIC BROTH A.O.A.C. |
| Classification | Kit, Fastidious Organisms |
| Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JST |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-23 |
| Decision Date | 1984-05-11 |