The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Theophylline Enzyme Immunoassay.
Device ID | K802066 |
510k Number | K802066 |
Device Name: | ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY |
Classification | Enzyme Immunoassay, Theophylline |
Applicant | IMMUNOTECH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KLS |
CFR Regulation Number | 862.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-27 |
Decision Date | 1980-10-23 |