The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem Otc Hcg Pregnancy Test For Consumer Use.
| Device ID | K863841 |
| 510k Number | K863841 |
| Device Name: | TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | Bruni, Phd |
| Correspondent | Bruni, Phd HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-01 |
| Decision Date | 1986-12-22 |