Preservative, Cytological
FDA product code LEA · Class I (low risk) · 21 CFR 864.4010 · Pathology
4510(k) clearances
0PMA approvals
4recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873594 | Tif Fecal TestLEA · Traditional | Devetec, Inc. | 09/29/1987SE |
| K770592 | Cytology FixativeLEA · Traditional | Surgipath Medical Industries, Inc. | 05/20/1977SE |
| K761001 | Pap-Tray II (Catalog #C600-2)LEA · Traditional | Lerner Laboratories, Inc. | 12/06/1976SE |
| K761000 | Pap-Tray I (Catalog #C600-1)LEA · Traditional | Lerner Laboratories, Inc. | 12/06/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1093-2026 Class II | ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.Fungal contamination of affected lot with Parengyodontium album. | Hologic, Inc | 12/12/2025Open, Classified |
| Z-1640-2015 Class II | Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx…Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer… | Richard-Allan Scientific Company | 04/29/2015Terminated |
| Z-1639-2015 Class II | Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying…Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer… | Richard-Allan Scientific Company | 04/29/2015Terminated |
| Z-1331-2012 | Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of…Product was distributed with the incorrect lot number and expiration date. The lot number and expiration… | Leica Biosystems Richmond Inc. | 02/20/2012Terminated |