The following data is part of a premarket notification filed by Jay Rau, Technical Suppprt with the FDA for Kallestad Quantizyme Theophylline Enzyme.
Device ID | K821154 |
510k Number | K821154 |
Device Name: | KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME |
Classification | Enzyme Immunoassay, Theophylline |
Applicant | JAY RAU, TECHNICAL SUPPPRT 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 | 1982-04-26 |
Decision Date | 1982-05-13 |