The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Amerlite Fsh Assay.
Device ID | K952285 |
510k Number | K952285 |
Device Name: | AMERLITE FSH ASSAY |
Classification | Radioimmunoassay, Follicle-stimulating Hormone |
Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
Contact | Yvonne E Middlefell |
Correspondent | Yvonne E Middlefell JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
Product Code | CGJ |
CFR Regulation Number | 862.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-16 |
Decision Date | 1995-07-03 |