Preservative, Cytological
Regulation 864.4010
0510(k)s in 12 months (4 all time)
1recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in LEA
| Company | 510(k)s | Recalls |
|---|---|---|
| Lerner Laboratories, Inc. | 2 | 0 |
| Richard-Allan Scientific Company | 0 | 2 |
| Devetec, Inc. | 1 | 0 |
| Hologic, Inc | 0 | 1 |
| Leica Biosystems Richmond Inc. | 0 | 1 |
| Surgipath Medical Industries, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2026 | Hologic, Inc ThinPrep CytoLyt Solution. Buffered Cell Wash Solution. Open, Classified |
LEA | None listed |
| May 21, 2015 | Richard-Allan Scientific Company Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L;
Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL
Product Usage:
A mucoliquefying preservative designed for use in the preparation of Terminated |
LEA | None listed |
| May 21, 2015 | Richard-Allan Scientific Company Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l
Product Usage:
A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus Terminated |
LEA | None listed |
| Mar 29, 2012 | Leica Biosystems Richmond Inc. Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cyt Terminated |
LEA | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.