Hematoxylin Stain Harris
FDA 510(k) K781585 · Bioscientific
510(k) numberK781585
Submission
- Device name
- Hematoxylin Stain Harris
- Applicant
- Bioscientific
Mchenry, IL, US - Received
- September 18, 1978
- Decision date
- October 10, 1978
- 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 |
| K800324 | Volu-Sol Harris HematoxylinHYK · Traditional | Volu Sol Medical Industries | 02/22/1980SE |
More from Volu Sol Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K812447 | Amylase Reagent KitKHM · Traditional | 09/09/1981SE |
| K811251 | Citrate BufferJCC · Traditional | 05/21/1981SE |
| K801268 | Hemoglobin Control LevelsKHG · Traditional | 07/14/1980SE |
| K801267 | Red Blood Cell Count & Hematocrit CNTLJPK · Traditional | 07/14/1980SE |
| K801265 | White Blood Cell Count Control LevelsJPK · Traditional | 07/14/1980SE |
| K791658 | Wright Stain Pack · Traditional | 10/17/1979SE |
| K791007 | Stat Diff StainKQC · Traditional | 08/03/1979SE |
| K790415 | HCP-7JPK · Traditional | 04/04/1979SE |
| K781734 | Sodium Chloride, 0.85% · Traditional | 10/24/1978SE |
| K781588 | Papanicolaou Stian OG-6HZJ · Traditional | 10/10/1978SE |
Questions and answers
When was Hematoxylin Stain Harris cleared by the FDA?
Hematoxylin Stain Harris (K781585) received a 510(k) decision of Substantially Equivalent on October 10, 1978, 22 days after the submission was received.
What is the product code of K781585?
The FDA product code is HYK – Hematoxylin Harris'S, a Class I (low risk) device regulated under 21 CFR 864.1850.