Hematoxylin Harris'S
FDA product code HYK · Class I (low risk) · 21 CFR 864.1850 · Hematology
7510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873107 | Instant HematoxylinHYK · Traditional | Shandon, Inc. | 08/21/1987SE |
| K872498 | Harris HematoxylinHYK · Traditional | Anatech, Ltd. | 07/09/1987SE |
| K843425 | Harris Hematoxylin, Mercury Free, AcidHYK · Traditional | Accra Laboratories, Inc. | 10/02/1984SE |
| K823328 | Harris HematoxylinHYK · Traditional | Accra Laboratories, Inc. | 12/28/1982SE |
| K810733 | Harris HematoxylinHYK · Traditional | Surgipath | 04/14/1981SE |
| K800324 | Volu-Sol Harris HematoxylinHYK · Traditional | Volu Sol Medical Industries | 02/22/1980SE |
| K781585 | Hematoxylin Stain HarrisHYK · Traditional | Bioscientific | 10/10/1978SE |