The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem(r)-m Fsh Immunoenzymetric Assay.
| Device ID | K870520 |
| 510k Number | K870520 |
| Device Name: | TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | Kabakoff, Phd |
| Correspondent | Kabakoff, Phd HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-06 |
| Decision Date | 1987-03-10 |