The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Ige-quant Diagnostic Test Kit.
Device ID | K831208 |
510k Number | K831208 |
Device Name: | IGE-QUANT DIAGNOSTIC TEST KIT |
Classification | Ige, Antigen, Antiserum, Control |
Applicant | LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DGC |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-14 |
Decision Date | 1983-05-09 |