The following data is part of a premarket notification filed by Monobind with the FDA for Anti-thyroid Peroxidase (tpo) Microplate Elisa.
| Device ID | K971834 |
| 510k Number | K971834 |
| Device Name: | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA |
| Classification | Immunochemical, Thyroglobulin Autoantibody |
| 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 | JNL |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-19 |
| Decision Date | 1997-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239041142 | K971834 | 000 |
| 00816870020396 | K971834 | 000 |
| 04048474041149 | K971834 | 000 |