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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 1987 | K873594 | TIF FECAL TEST Devetec, Inc. | LEA |
| May 20, 1977 | K770592 | CYTOLOGY FIXATIVE Surgipath Medical Industries, Inc. | LEA |
| Dec 6, 1976 | K761001 | PAP-TRAY II (CATALOG #C600-2) Lerner Laboratories, Inc. | LEA |
| Dec 6, 1976 | K761000 | PAP-TRAY I (CATALOG #C600-1) Lerner Laboratories, Inc. | LEA |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.