The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Fisher Diagnostics Pregnaclone Slide Pregnancy Tes.
| Device ID | K844346 |
| 510k Number | K844346 |
| Device Name: | FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | FISHER DIAGNOSTICS 526 ROUTE 303 Orangeburg, NY 10962 |
| Contact | Charles B Breuer |
| Correspondent | Charles B Breuer FISHER DIAGNOSTICS 526 ROUTE 303 Orangeburg, NY 10962 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-09 |
| Decision Date | 1985-03-04 |