The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Theophylline Calibrators.
Device ID | K945338 |
510k Number | K945338 |
Device Name: | THEOPHYLLINE CALIBRATORS |
Classification | Calibrators, Drug Specific |
Applicant | DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
Contact | Yuh-gen Tsay |
Correspondent | Yuh-gen Tsay DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
Product Code | DLJ |
CFR Regulation Number | 862.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-01 |
Decision Date | 1995-01-17 |