The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Theophylline Immunoassay Reagents.
Device ID | K922823 |
510k Number | K922823 |
Device Name: | ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS |
Classification | Acid, Folic, Radioimmunoassay |
Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Contact | Jan Olsen |
Correspondent | Jan Olsen BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Product Code | CGN |
CFR Regulation Number | 862.1295 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-11 |
Decision Date | 1992-08-05 |