The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for Theophylline Test Kit Ref. #a874799.
| Device ID | K880291 |
| 510k Number | K880291 |
| Device Name: | THEOPHYLLINE TEST KIT REF. #A874799 |
| Classification | Radioimmunoassay, Theophylline |
| Applicant | PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
| Contact | Robert P Henry |
| Correspondent | Robert P Henry PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
| Product Code | LCA |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-25 |
| Decision Date | 1988-03-24 |