The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Coated Tube Hcg Immunoassay Hcg.
| Device ID | K841023 |
| 510k Number | K841023 |
| Device Name: | COATED TUBE HCG IMMUNOASSAY HCG |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | VENTREX LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-12 |
| Decision Date | 1984-05-01 |