Volu-Sol Statim Stain
FDA 510(k) K792497 · Volu Sol Medical Industries
510(k) numberK792497
Submission
- Device name
- Volu-Sol Statim Stain
- Applicant
- Volu Sol Medical Industries
- Received
- December 4, 1979
- Decision date
- December 18, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IAF – Wright'S Stain
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code IAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890674 | Accustain(Tm) - Automated Wright Giemsa Stain SetIAF · Traditional | Sigma Diagnostics, Inc. | 02/24/1989SE |
| K890673 | Wright-Glemsa StainIAF · Traditional | Sigma Diagnostics, Inc. | 02/24/1989SE |
| K854236 | Histamine Ria Test for Histamine Biological FluidsIAF · Traditional | Nms Pharmaceuticals, Inc. | 10/10/1986SN |
| K860793 | Camco Stain PakIAF · Traditional | Cambridge Chemical Products, Inc. | 03/18/1986SE |
| K853241 | Hematology Stain PackIAF · Traditional | Fisher Scientific Co., LLC | 08/19/1985SE |
| K852138 | Wescor Stain Pack for Model 7100 Aerospray Slide SIAF · Traditional | Canyon Diagnostics, Inc. | 06/13/1985SE |
| K842744 | Wright StainIAF · Traditional | E K Ind., Inc. | 08/12/1984SE |
| K842745 | Wright-Giemsa Quick StainIAF · Traditional | E K Ind., Inc. | 08/10/1984SE |
| K833678 | Hematology Wright's Stain PackIAF · Traditional | J.S. Medical Assoc. | 11/25/1983SE |
| K833260 | Stain Pack for Aerospray Slide StainerIAF · Traditional | Wescor, Inc. | 10/28/1983SE |
More from Wescor, Inc.
| 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 Statim Stain cleared by the FDA?
Volu-Sol Statim Stain (K792497) received a 510(k) decision of Substantially Equivalent on December 18, 1979, 14 days after the submission was received.
What is the product code of K792497?
The FDA product code is IAF – Wright'S Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.