The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandemr Iconr Ii Hcg(serum) Immunoenzymetric Assay.
| Device ID | K865057 |
| 510k Number | K865057 |
| Device Name: | TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | Bruni, Ph.d. |
| Correspondent | Bruni, Ph.d. HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-24 |
| Decision Date | 1987-03-10 |