The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Fsh Serozyme Immunoenzymetric Assay Kit/mag Sep Ph.
| Device ID | K872627 |
| 510k Number | K872627 |
| Device Name: | FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell, MA 02061 |
| Contact | Philip M Fantasia |
| Correspondent | Philip M Fantasia SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell, MA 02061 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-06 |
| Decision Date | 1987-07-21 |