The following data is part of a premarket notification filed by Bioclinical Systems, Inc. with the FDA for Micro-eia Theophylline Test Kit Monoclonal.
| Device ID | K855227 |
| 510k Number | K855227 |
| Device Name: | MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | BIOCLINICAL SYSTEMS, INC. 5977 SOUTHWEST AVE. St.louis, MO 63139 |
| Contact | Bruce F Watkins |
| Correspondent | Bruce F Watkins BIOCLINICAL SYSTEMS, INC. 5977 SOUTHWEST AVE. St.louis, MO 63139 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-30 |
| Decision Date | 1986-04-11 |