The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Turbox Theophylline Assay.
Device ID | K882570 |
510k Number | K882570 |
Device Name: | TURBOX THEOPHYLLINE ASSAY |
Classification | Fluorescent Immunoassay, Theophylline |
Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
Contact | Mr. G Zajicek |
Correspondent | Mr. G Zajicek UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
Product Code | LER |
CFR Regulation Number | 862.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-22 |
Decision Date | 1988-11-10 |