The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Escherichia Coli 0157 Latex Agglutination Test Kit.
| Device ID | K884026 |
| 510k Number | K884026 |
| Device Name: | ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT |
| Classification | Antisera, All Types, Escherichia Coli |
| Applicant | OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Maryalice Francisco |
| Correspondent | Maryalice Francisco OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | GNA |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-23 |
| Decision Date | 1989-02-03 |