The following data is part of a premarket notification filed by Lerner Laboratories, Inc. with the FDA for Pap-tray I (catalog #c600-1).
| Device ID | K761000 |
| 510k Number | K761000 |
| Device Name: | PAP-TRAY I (CATALOG #C600-1) |
| Classification | Preservative, Cytological |
| Applicant | LERNER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LEA |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-11-08 |
| Decision Date | 1976-12-06 |