The following data is part of a premarket notification filed by Monobind with the FDA for Free T4 (thytoxine) Microplate Eia Test Models # 1225-300.
| Device ID | K020548 |
| 510k Number | K020548 |
| Device Name: | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 |
| Classification | Radioimmunoassay, Free 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 | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013156 | K020548 | 000 |
| 00840239042668 | K020548 | 000 |
| 00816870021744 | K020548 | 000 |
| 00816870021737 | K020548 | 000 |
| 00816870021720 | K020548 | 000 |
| 00816870021713 | K020548 | 000 |
| 04048474042665 | K020548 | 000 |