Bio-Dyes Hematology Phosphate
FDA 510(k) K770075 · Jack W. Kindberg
510(k) numberK770075
Submission
- Device name
- Bio-Dyes Hematology Phosphate
- Applicant
- Jack W. Kindberg
Mchenry, IL, US - Received
- January 13, 1977
- Decision date
- March 22, 1977
- 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.
Questions and answers
When was Bio-Dyes Hematology Phosphate cleared by the FDA?
Bio-Dyes Hematology Phosphate (K770075) received a 510(k) decision of Substantially Equivalent on March 22, 1977, 68 days after the submission was received.
What is the product code of K770075?
The FDA product code is IAF – Wright'S Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.