Gill Hematoxylin Stain
FDA 510(k) K842741 · E K Ind., Inc.
510(k) numberK842741
Submission
- Device name
- Gill Hematoxylin Stain
- Applicant
- E K Ind., Inc.
Mchenry, IL, US - Received
- July 13, 1984
- Decision date
- August 15, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HYJ – Hematoxylin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HYJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872500 | Anatech Hematoxylin-Extra StrengthHYJ · Traditional | Anatech, Ltd. | 07/09/1987SE |
| K872499 | Anatech Hematoxylin-Normal StrengthHYJ · Traditional | Anatech, Ltd. | 07/09/1987SE |
| K842740 | Delafield Hematoxylin StainHYJ · Traditional | E K Ind., Inc. | 08/17/1984SE |
| K831090 | Hematoxylin Gill Formulation IX#56016HYJ · Traditional | Accra Laboratories, Inc. | 06/08/1983SE |
| K822352 | Hematoxylin Stain SolutionHYJ · Traditional | Fisher Scientific Co., LLC | 08/16/1982SE |
| K821541 | Hematoxylin IIIHYJ · Traditional | Volu Sol Medical Industries | 06/10/1982SE |
| K821540 | Hematoxylin IIHYJ · Traditional | Volu Sol Medical Industries | 06/10/1982SE |
| K821533 | Hematoxylin IHYJ · Traditional | Volu Sol Medical Industries | 06/10/1982SE |
| K821320 | Hematoxylin StainHYJ · Traditional | Sigma Chemical Co. | 06/02/1982SE |
| K821062 | Hematoxylin SolutionHYJ · Traditional | Sigma Chemical Co. | 04/29/1982SE |
More from Sigma Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K842931 | Drabkin ReagentKAG · Traditional | 09/21/1984SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | 09/12/1984SE |
| K842936 | Acetic Acid, 3% V/VGGK · Traditional | 09/12/1984SE |
| K842935 | Acetic Acid, 5% V/VGGK · Traditional | 09/12/1984SE |
| K842934 | Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional | 09/12/1984SE |
| K842933 | Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional | 09/11/1984SE |
| K842930 | Gomori's Trichrome StainLED · Traditional | 09/11/1984SE |
| K842928 | Jenner Blood StainKJX · Traditional | 09/11/1984SE |
| K842927 | Light Green SF 1%HYS · Traditional | 09/11/1984SE |
Questions and answers
When was Gill Hematoxylin Stain cleared by the FDA?
Gill Hematoxylin Stain (K842741) received a 510(k) decision of Substantially Equivalent on August 15, 1984, 33 days after the submission was received.
What is the product code of K842741?
The FDA product code is HYJ – Hematoxylin, a Class I (low risk) device regulated under 21 CFR 864.1850.