The following data is part of a premarket notification filed by Remel Co. with the FDA for Rim E.coli 0157:h7 Latex Test.
| Device ID | K933457 |
| 510k Number | K933457 |
| Device Name: | RIM E.COLI 0157:H7 LATEX TEST |
| Classification | Antisera, All Types, Escherichia Coli |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | David A Wall |
| Correspondent | David A Wall REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | GNA |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-14 |
| Decision Date | 1994-04-20 |