The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Ames Tda Tm Amikacin Test.
Device ID | K811026 |
510k Number | K811026 |
Device Name: | AMES TDA TM AMIKACIN TEST |
Classification | Radioimmunoassay, Amikacin |
Applicant | MILES LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KLQ |
CFR Regulation Number | 862.3035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-16 |
Decision Date | 1981-04-29 |