The following data is part of a premarket notification filed by Franklin Diagnostics, Inc. with the FDA for Thyrochek One-step Rapid Tsh Assay.
| Device ID | K960195 |
| 510k Number | K960195 |
| Device Name: | THYROCHEK ONE-STEP RAPID TSH ASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | FRANKLIN DIAGNOSTICS, INC. 140 HANOVER AVE. Cedar Knolls, NJ 07927 |
| Contact | J Ehrenkranz |
| Correspondent | J Ehrenkranz FRANKLIN DIAGNOSTICS, INC. 140 HANOVER AVE. Cedar Knolls, NJ 07927 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-04-15 |
| Summary: | summary |