The following data is part of a premarket notification filed by Canadian Bioclinical, Ltd. with the FDA for Ani Biocard(tm) Hcg Test.
| Device ID | K933794 |
| 510k Number | K933794 |
| Device Name: | ANI BIOCARD(TM) HCG TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | CANADIAN BIOCLINICAL, LTD. 120 WEST BEAVER CREEK RICHMOND HILL Ontario, Canada, CA L4b 1l2 |
| Contact | Jeremy Clapp |
| Correspondent | Jeremy Clapp CANADIAN BIOCLINICAL, LTD. 120 WEST BEAVER CREEK RICHMOND HILL Ontario, Canada, CA L4b 1l2 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-04 |
| Decision Date | 1994-05-19 |