The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Behring Polaroid Opus Theophylline.
| Device ID | K885044 |
| 510k Number | K885044 |
| Device Name: | BEHRING POLAROID OPUS THEOPHYLLINE |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Deborah B Grabbe |
| Correspondent | Deborah B Grabbe PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-05 |
| Decision Date | 1988-12-29 |