The following data is part of a premarket notification filed by Monobind with the FDA for Total Throxine Microplate Eia(225-300).
| Device ID | K971709 |
| 510k Number | K971709 |
| Device Name: | TOTAL THROXINE MICROPLATE EIA(225-300) |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| 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 | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-08 |
| Decision Date | 1997-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816870021683 | K971709 | 000 |
| 00816870021676 | K971709 | 000 |
| 00816870021669 | K971709 | 000 |
| 00816870021652 | K971709 | 000 |
| 00840239052797 | K971709 | 000 |
| 04048474052794 | K971709 | 000 |