The following data is part of a premarket notification filed by Monobind with the FDA for Follicle Stimulating Hormone (fsh) Microplate Elisa (425-300).
| Device ID | K972720 |
| 510k Number | K972720 |
| Device Name: | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) |
| Classification | Radioimmunoassay, Follicle-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 | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-21 |
| Decision Date | 1997-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816870020914 | K972720 | 000 |
| 00816870020907 | K972720 | 000 |
| 00840239040985 | K972720 | 000 |
| 04048474040982 | K972720 | 000 |