The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Amerlite Hcg-60 Assay.
| Device ID | K952283 |
| 510k Number | K952283 |
| Device Name: | AMERLITE HCG-60 ASSAY |
| Classification | System, Test, Human Chorionic Gonadotropin |
| 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 | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-16 |
| Decision Date | 1995-07-17 |