The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Total Bhcg Assay (modification).
Device ID | K954732 |
510k Number | K954732 |
Device Name: | ACCESS TOTAL BHCG ASSAY (MODIFICATION) |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Contact | Dennis Griffin |
Correspondent | Dennis Griffin BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-02 |
Decision Date | 1995-11-20 |