Hematoxylin III
FDA 510(k) K821541 · Volu Sol Medical Industries
510(k) numberK821541
Submission
- Device name
- Hematoxylin III
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- May 24, 1982
- Decision date
- June 10, 1982
- 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 |
| K842741 | Gill Hematoxylin StainHYJ · Traditional | E K Ind., Inc. | 08/15/1984SE |
| 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 |
| 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 |
|---|---|---|
| K822129 | Volu-Sol Bovins FixativeIGN · Traditional | 08/05/1982SE |
| K822128 | Volu-Sol Single Differential StainICN · Traditional | 08/05/1982SE |
| K822127 | Volu-Sol Zenkers FixativeIFH · Traditional | 08/05/1982SE |
| K822126 | Volu-Sol Carnoy FluidIGM · Traditional | 08/05/1982SE |
| K822038 | Volu-Sol Orange G-6(GILLS-MODHZH · Traditional | 08/03/1982SE |
| K822037 | Volu-Sol Tap Water SubstitutePPM · Traditional | 08/03/1982SE |
| K822036 | Volu-Sol DecalciferKDX · Traditional | 08/03/1982SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | 08/03/1982SE |
| K812906 | Elvi Biclot 816KQG · Traditional | 07/22/1982SE |
| K821540 | Hematoxylin IIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Hematoxylin III cleared by the FDA?
Hematoxylin III (K821541) received a 510(k) decision of Substantially Equivalent on June 10, 1982, 17 days after the submission was received.
What is the product code of K821541?
The FDA product code is HYJ – Hematoxylin, a Class I (low risk) device regulated under 21 CFR 864.1850.