The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quanticoat 125 I-theophylline Radioimm..
Device ID | K821862 |
510k Number | K821862 |
Device Name: | QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. |
Classification | Radioimmunoassay, Theophylline |
Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LCA |
CFR Regulation Number | 862.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-24 |
Decision Date | 1982-07-06 |