The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for E. Coli 0157 Elisa Stool Assay.
| Device ID | K942705 |
| 510k Number | K942705 |
| Device Name: | E. COLI 0157 ELISA STOOL ASSAY |
| Classification | Antigens, All Types, Escherichia Coli |
| Applicant | LMD LABORATORIES 2792 LOKER AVE., WEST, #103 SUITE 103 Carlsbad, CA 92008 |
| Contact | Dave Lambillotte |
| Correspondent | Dave Lambillotte LMD LABORATORIES 2792 LOKER AVE., WEST, #103 SUITE 103 Carlsbad, CA 92008 |
| Product Code | GMZ |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-08 |
| Decision Date | 1995-09-27 |