The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem Hcg Immunoezymetric Assay Kit.
| Device ID | K821944 |
| 510k Number | K821944 |
| Device Name: | TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | HYBRITECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-29 |
| Decision Date | 1982-07-22 |