The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Optimate Iga Test.
Device ID | K841815 |
510k Number | K841815 |
Device Name: | OPTIMATE IGA TEST |
Classification | Iga, Fitc, Antigen, Antiserum, Control |
Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CZN |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-01 |
Decision Date | 1984-06-01 |