The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem-e Fsh Immunoenzymetric Assay Kit.
| Device ID | K894761 |
| 510k Number | K894761 |
| Device Name: | TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | Martinis, Phd |
| Correspondent | Martinis, 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 | 1989-07-27 |
| Decision Date | 1989-09-13 |