Stain Pack for Aerospray Slide Stainer
FDA 510(k) K833260 · Wescor, Inc.
510(k) numberK833260
Submission
- Device name
- Stain Pack for Aerospray Slide Stainer
- Applicant
- Wescor, Inc.
Mchenry, IL, US - Received
- September 23, 1983
- Decision date
- October 28, 1983
- 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 |
| K831605 | Hematology PakIAF · Traditional | Mercedes Scientific Co., Inc. | 06/30/1983SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K121823 | Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer…JFS · Traditional | 03/27/2013SE |
| K010031 | Nanoduct Neonatal Sweat Analysis SystemKTB · Special | 03/20/2001SE |
| K863395 | Wescor Sweat.Chek Sweat Conductivity AnalyzerCGZ · Traditional | 05/24/1988SE |
| K881592 | Wescor Model 7300 Aerospray Gram StainerKPA · Traditional | 05/13/1988SE |
| K881512 | Wescor Gram Stain Pack for Model 7300 AerosprayJTS · Traditional | 04/18/1988SE |
| K880544 | Wescor Stain Concentrate for Model 7100 AerosprayGJL · Traditional | 04/01/1988SE |
| K853973 | Wescor Model 3700 Webster Sweat InducerKTB · Traditional | 10/16/1985SE |
| K834214 | Wescor 5500 Vapor Pressure OsmometerJJM · Traditional | 03/30/1984SE |
| K834208 | Colloid Osmometer 4400JJM · Traditional | 03/23/1984SE |
| K840472 | Sys Macroduct Sweat Collection Sys 3600KTB · Traditional | 03/19/1984SE |
Questions and answers
When was Stain Pack for Aerospray Slide Stainer cleared by the FDA?
Stain Pack for Aerospray Slide Stainer (K833260) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 35 days after the submission was received.
What is the product code of K833260?
The FDA product code is IAF – Wright'S Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.