Wescor 7100 Aerospray Slide Stainer
FDA 510(k) K833295 · Wescor, Inc.
510(k) numberK833295
Submission
- Device name
- Wescor 7100 Aerospray Slide Stainer
- Applicant
- Wescor, Inc.
Mchenry, IL, US - Received
- September 23, 1983
- Decision date
- October 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933996 | ProfiblotKPA · Traditional | Tecan U.S., Ltd. | 01/28/1994SE |
| K884258 | VersablotKPA · Traditional | American Bionetics, Inc. | 12/14/1988SE |
| K881592 | Wescor Model 7300 Aerospray Gram StainerKPA · Traditional | Wescor, Inc. | 05/13/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | Innovative Medical Systems, Inc. | 04/27/1988SE |
| K874887 | Wesblot ProcessorKPA · Traditional | American Bionetics, Inc. | 03/24/1988SE |
| K874897 | Sakura DRS-60 Automatic Slide StainerKPA · Traditional | Sakura Finetek U.S.A., Inc. | 01/05/1988SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | Fisher Scientific Co., LLC | 09/14/1987SE |
| K853210 | MST-1050-II X-Ray UnitKPA · Traditional | Radiological Engineering, Inc. | 10/10/1985SE |
| K850333 | Pump Tube Sets for Hema-Tek I & II Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
| K850157 | Cannulas for Hema-Tek I & KK Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
More from Shaban Mfg. Co.
| 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 Wescor 7100 Aerospray Slide Stainer cleared by the FDA?
Wescor 7100 Aerospray Slide Stainer (K833295) received a 510(k) decision of Substantially Equivalent on October 31, 1983, 38 days after the submission was received.
What is the product code of K833295?
The FDA product code is KPA – Slide Stainer, Automated, a Class I (low risk) device regulated under 21 CFR 864.3800.