Volu-Sol Histo./Cyto. Stain Mod. #EA65
FDA 510(k) K800325 · Volu Sol Medical Industries
510(k) numberK800325
Submission
- Device name
- Volu-Sol Histo./Cyto. Stain Mod. #EA65
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- February 12, 1980
- Decision date
- February 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HZJ – Stain, Papanicolau
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K843427 | Gill Papanicolaou Stain EA-1 & 2 OG-6HZJ · Traditional | Accra Laboratories, Inc. | 10/02/1984SE |
| K842739 | Pap Stain, EA-36HZJ · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K842735 | Pap Stain EA-65HZJ · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K842738 | Pap Stain EA-50HZJ · Traditional | E K Ind., Inc. | 08/17/1984SE |
| K842736 | Pap Stain, OG-6HZJ · Traditional | E K Ind., Inc. | 08/17/1984SE |
| K840054 | Papanicolaou Stain Sys HT40HZJ · Traditional | Sigma Chemical Co. | 02/17/1984SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | Volu Sol Medical Industries | 08/03/1982SE |
| K820027 | Modified Ea 50HZJ · Traditional | Surgipath | 02/04/1982SE |
| K812087 | Ea 50HZJ · Traditional | Surgipath | 08/13/1981SE |
| K812086 | Ea 65HZJ · Traditional | Surgipath | 08/13/1981SE |
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 Histo./Cyto. Stain Mod. #EA65 cleared by the FDA?
Volu-Sol Histo./Cyto. Stain Mod. #EA65 (K800325) received a 510(k) decision of Substantially Equivalent on February 26, 1980, 14 days after the submission was received.
What is the product code of K800325?
The FDA product code is HZJ – Stain, Papanicolau, a Class I (low risk) device regulated under 21 CFR 864.1850.