The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Ria Quant B-hcg Test Kit.
| Device ID | K781578 |
| 510k Number | K781578 |
| Device Name: | RIA QUANT B-HCG TEST KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | MALLINCKRODT CRITICAL CARE 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 | 1978-09-15 |
| Decision Date | 1978-10-10 |