The following data is part of a premarket notification filed by Monobind with the FDA for Total Triiodothyronine(t3) Microplate Eia.
| Device ID | K971779 |
| 510k Number | K971779 |
| Device Name: | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | MONOBIND 729 WEST 16TH ST., C-4 Costa Mesa, CA 92627 |
| Contact | Frederick R Jerome |
| Correspondent | Frederick R Jerome MONOBIND 729 WEST 16TH ST., C-4 Costa Mesa, CA 92627 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-14 |
| Decision Date | 1997-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B24225TRIHUE010 | K971779 | 000 |
| 00816870021560 | K971779 | 000 |
| 00816870021553 | K971779 | 000 |
| 00816870021546 | K971779 | 000 |
| 00816870021539 | K971779 | 000 |
| 00840239052759 | K971779 | 000 |
| 04048474041071 | K971779 | 000 |
| 04048474052770 | K971779 | 000 |
| 04048474052756 | K971779 | 000 |