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 |