K761001 is an FDA 510(k) clearance for the PAP-TRAY II (CATALOG #C600-2). This device is classified as a Preservative, Cytological (Class I - General Controls, product code LEA).
Submitted by Lerner Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1976, 28 days after receiving the submission on November 8, 1976.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K761001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1976 |
| Decision Date | December 06, 1976 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | LEA — Preservative, Cytological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.4010 |