The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Amerlite Tsh-30 Ultrasensitive Assay (lan.0010q/2010q).
| Device ID | K952211 |
| 510k Number | K952211 |
| Device Name: | AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Contact | Bradford M Spring |
| Correspondent | Bradford M Spring JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-11 |
| Decision Date | 1995-07-14 |