The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Qms(tm) - Theophylline.
| Device ID | K885263 |
| 510k Number | K885263 |
| Device Name: | QMS(TM) - THEOPHYLLINE |
| Classification | Nephelometer, For Clinical Use |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | J Sullivan |
| Correspondent | J Sullivan SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | JQX |
| CFR Regulation Number | 862.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-23 |
| Decision Date | 1989-03-28 |