Hematology Stain Pack
FDA 510(k) K781587 · Bioscientific
510(k) numberK781587
Submission
- Device name
- Hematology Stain Pack
- 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
- 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 |
|---|---|---|
| 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 Hematology Stain Pack cleared by the FDA?
Hematology Stain Pack (K781587) 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 K781587?
The FDA product code is IAF – Wright'S Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.