The following data is part of a premarket notification filed by Repromedix Corp. with the FDA for Reprobead Tsh Enzyme Immunoassay Reagent Kit (catalog# 107).
| Device ID | K001606 |
| 510k Number | K001606 |
| Device Name: | REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | REPROMEDIX CORP. 86 CUMMINGS PARK, Woburn, MA 01801 |
| Contact | Han-soo Kim |
| Correspondent | Han-soo Kim REPROMEDIX CORP. 86 CUMMINGS PARK, Woburn, MA 01801 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-24 |
| Decision Date | 2000-10-05 |