The following data is part of a premarket notification filed by Bioclinical Systems, Inc. with the FDA for Now Home Pregn. Test Kit Enzyme Immunoassay Hcg.
| Device ID | K850079 |
| 510k Number | K850079 |
| Device Name: | NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | BIOCLINICAL SYSTEMS, INC. 5977 SOUTHWEST AVE. St.louis, MO 63139 |
| Contact | Bruce F Watkins |
| Correspondent | Bruce F Watkins BIOCLINICAL SYSTEMS, INC. 5977 SOUTHWEST AVE. St.louis, MO 63139 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-10 |
| Decision Date | 1985-03-05 |