The following data is part of a premarket notification filed by Immunostics Co., Inc. with the FDA for Slide Pregnancy Test.
| Device ID | K842110 |
| 510k Number | K842110 |
| Device Name: | SLIDE PREGNANCY TEST |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | IMMUNOSTICS CO., INC. 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 | 1984-05-29 |
| Decision Date | 1984-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10722355001446 | K842110 | 000 |