The following data is part of a premarket notification filed by Cetus Corp. with the FDA for Epichrome Pap.
| Device ID | K844968 |
| 510k Number | K844968 |
| Device Name: | EPICHROME PAP |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | CETUS CORP. 1400 FIFTY-THIRD ST. Emeryville, CA 94608 |
| Contact | Wanda Devlaminck |
| Correspondent | Wanda Devlaminck CETUS CORP. 1400 FIFTY-THIRD ST. Emeryville, CA 94608 |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-24 |
| Decision Date | 1985-02-07 |