The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Qms Theophylline Cs.
| Device ID | K942991 |
| 510k Number | K942991 |
| Device Name: | QMS THEOPHYLLINE CS |
| Classification | Fluorescence Polarization Immunoassay, Theophylline |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Andris Indriksons |
| Correspondent | Andris Indriksons SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | LGS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-20 |
| Decision Date | 1994-09-09 |