The following data is part of a premarket notification filed by Monobind with the FDA for Accubind Neonatal T4 Microplate Eia, Model 2625-300.
| Device ID | K030860 |
| 510k Number | K030860 |
| Device Name: | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | MONOBIND 729 WEST 16TH ST., C-4 Costa Mesa, CA 92627 |
| Contact | Jay Singh |
| Correspondent | Jay Singh MONOBIND 729 WEST 16TH ST., C-4 Costa Mesa, CA 92627 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-18 |
| Decision Date | 2003-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239041098 | K030860 | 000 |
| 00816870021256 | K030860 | 000 |
| 00816870021249 | K030860 | 000 |
| 00816870021232 | K030860 | 000 |
| 00816870021225 | K030860 | 000 |
| 00816870021218 | K030860 | 000 |
| 04048474041095 | K030860 | 000 |