The following data is part of a premarket notification filed by Monobind with the FDA for T-uptake Microplate Eia.
| Device ID | K980088 |
| 510k Number | K980088 |
| Device Name: | T-UPTAKE MICROPLATE EIA |
| Classification | Radioassay, Triiodothyronine Uptake |
| 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 | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-09 |
| Decision Date | 1998-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816870021607 | K980088 | 000 |
| 00816870021591 | K980088 | 000 |