The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for B-slide Pregnate Pregnancy Test Kit.
| Device ID | K832879 |
| 510k Number | K832879 |
| Device Name: | B-SLIDE PREGNATE PREGNANCY TEST KIT |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-26 |
| Decision Date | 1983-10-28 |