The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Diagnostic Kit, Ferritab-fe-59.
Device ID | K782159 |
510k Number | K782159 |
Device Name: | DIAGNOSTIC KIT, FERRITAB-FE-59 |
Classification | Radio-labeled Iron Method, Iron (non-heme) |
Applicant | LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJA |
CFR Regulation Number | 862.1410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-22 |
Decision Date | 1979-02-01 |