Volu-Sol Harris Hematoxylin
FDA 510(k) K800324 · Volu Sol Medical Industries
510(k) numberK800324
Submission
- Device name
- Volu-Sol Harris Hematoxylin
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- February 12, 1980
- Decision date
- February 22, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HYK – Hematoxylin Harris'S
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HYK
| 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 |
| K781585 | Hematoxylin Stain HarrisHYK · Traditional | Bioscientific | 10/10/1978SE |
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| 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 |
| K821541 | Hematoxylin IIIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Volu-Sol Harris Hematoxylin cleared by the FDA?
Volu-Sol Harris Hematoxylin (K800324) received a 510(k) decision of Substantially Equivalent on February 22, 1980, 10 days after the submission was received.
What is the product code of K800324?
The FDA product code is HYK – Hematoxylin Harris'S, a Class I (low risk) device regulated under 21 CFR 864.1850.