The following data is part of a premarket notification filed by Monobind with the FDA for Thyrotropin(tsh) Elisa.
| Device ID | K971780 |
| 510k Number | K971780 |
| Device Name: | THYROTROPIN(TSH) ELISA |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| 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 | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-14 |
| Decision Date | 1997-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239041111 | K971780 | 000 |
| 00816870021812 | K971780 | 000 |
| 00816870021805 | K971780 | 000 |
| 00816870021799 | K971780 | 000 |
| 00816870021782 | K971780 | 000 |
| 04048474041118 | K971780 | 000 |
| 04048474052831 | K971780 | 000 |
| 04048474052664 | K971780 | 000 |