The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Hybritech Stratus Pap Fluorometric Enzyme Immuno.
| Device ID | K921745 |
| 510k Number | K921745 |
| Device Name: | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | HYBRITECH, INC. P.O. BOX 269006 San Diego, CA 92196 |
| Contact | Joanne Martinis |
| Correspondent | Joanne Martinis HYBRITECH, INC. P.O. BOX 269006 San Diego, CA 92196 |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-13 |
| Decision Date | 1992-07-30 |