The following data is part of a premarket notification filed by Monobind, Inc. with the FDA for Accubind Neo-tsh Microwell Elisa, Model 3425-300.
| Device ID | K063437 |
| 510k Number | K063437 |
| Device Name: | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | MONOBIND, INC. 100 N. POINTE DR. Lake Forest, CA 92630 |
| Contact | Jay Singh |
| Correspondent | Jay Singh MONOBIND, INC. 100 N. POINTE DR. Lake Forest, CA 92630 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-14 |
| Decision Date | 2008-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816870021157 | K063437 | 000 |
| 00816870021140 | K063437 | 000 |
| 00816870021133 | K063437 | 000 |
| 00816870021126 | K063437 | 000 |
| 00816870021119 | K063437 | 000 |