The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem Pap Kit - (parts I & Ii).
| Device ID | K811959 |
| 510k Number | K811959 |
| Device Name: | TANDEM PAP KIT - (PARTS I & II) |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | HYBRITECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-09 |
| Decision Date | 1981-09-01 |