The following data is part of a premarket notification filed by Little Nell Labs, Inc. with the FDA for Thyrochek One-step Whole Blood Rapid Tsh Assay.
| Device ID | K990658 |
| 510k Number | K990658 |
| Device Name: | THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | LITTLE NELL LABS, INC. 1676 EAST SOPRIS CREEK RD. Basalt, CO 81621 |
| Contact | Joel R. L. Ehrenkranz |
| Correspondent | Joel R. L. Ehrenkranz LITTLE NELL LABS, INC. 1676 EAST SOPRIS CREEK RD. Basalt, CO 81621 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-06-02 |
| Summary: | summary |