The following data is part of a premarket notification filed by Bioclinical Systems, Inc. with the FDA for Micro-elisa Hcg Est Kit Visi-check Hcg Test Kit No.
| Device ID | K854059 |
| 510k Number | K854059 |
| Device Name: | MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-03 |
| Decision Date | 1986-01-13 |