The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Ames Tda Tobramycin Test.
Device ID | K810941 |
510k Number | K810941 |
Device Name: | AMES TDA TOBRAMYCIN TEST |
Classification | Fluorescent Immunoassay, Tobramycin |
Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LCR |
CFR Regulation Number | 862.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-07 |
Decision Date | 1981-04-17 |