Volu-Sol Eosin Y Stain
FDA 510(k) K800942 · Volu Sol Medical Industries
510(k) numberK800942
Submission
- Device name
- Volu-Sol Eosin Y Stain
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- April 22, 1980
- Decision date
- May 8, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HYB – Eosin Y
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893663 | Instant Eosin-AqueousHYB · Traditional | Shandon, Inc. | 06/13/1989SE |
| K880596 | Eosin Y Solution, Alcoholic, with PhloxineHYB · Traditional | Sigma Chemical Co. | 03/31/1988SE |
| K880240 | Instant Eosin-AlcoholicHYB · Traditional | Shandon, Inc. | 03/03/1988SE |
| K843426 | Eosin Y 1% AlcoholicHYB · Traditional | Accra Laboratories, Inc. | 09/27/1984SE |
| K822982 | Midas 100 Hemacolor Stain #66030HYB · Traditional | Emd Chemicals, Inc. | 10/27/1982SE |
| K821574 | Eosin Y Solutin, AgueousHYB · Traditional | Sigma Chemical Co. | 06/10/1982SE |
| K821573 | Eosin Y Solution AlcholicHYB · Traditional | Sigma Chemical Co. | 06/09/1982SE |
| K811797 | Eosin-YHYB · Traditional | Richard-Allan Medical Ind., Inc. | 07/28/1981SE |
| K811826 | Eosin YHYB · Traditional | Surgipath | 07/10/1981SE |
More from Surgipath
| 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 |
| K821541 | Hematoxylin IIIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Volu-Sol Eosin Y Stain cleared by the FDA?
Volu-Sol Eosin Y Stain (K800942) received a 510(k) decision of Substantially Equivalent on May 8, 1980, 16 days after the submission was received.
What is the product code of K800942?
The FDA product code is HYB – Eosin Y, a Class I (low risk) device regulated under 21 CFR 864.1850.