The following data is part of a premarket notification filed by Golden Bridge International, Inc. with the FDA for Gbi Tsh Neonatal Screening Kit.
| Device ID | K072458 |
| 510k Number | K072458 |
| Device Name: | GBI TSH NEONATAL SCREENING KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | GOLDEN BRIDGE INTERNATIONAL, INC. 9700 HARBOUR PL. SUITE 129 Mukilteo, WA 98275 |
| Contact | Xiaoping Zhang |
| Correspondent | Xiaoping Zhang GOLDEN BRIDGE INTERNATIONAL, INC. 9700 HARBOUR PL. SUITE 129 Mukilteo, WA 98275 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-31 |
| Decision Date | 2008-04-10 |
| Summary: | summary |