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 |