Cannulas for Hema-Tek I & KK Slide Stainers
FDA 510(k) K850157 · Shaban Mfg. Co.
510(k) numberK850157
Submission
- Device name
- Cannulas for Hema-Tek I & KK Slide Stainers
- Applicant
- Shaban Mfg. Co.
Fort Myers, FL, US - Received
- January 15, 1985
- Decision date
- February 27, 1985
- 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 |
| K842077 | Midas II Automatic StainerKPA · Traditional | Innovative Medical Systems, Inc. | 07/27/1984SE |
More from Innovative Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K853621 | Replacement Pump TubingJJE · Traditional | 12/05/1985SE |
| K850333 | Pump Tube Sets for Hema-Tek I & II Slide StainersKPA · Traditional | 02/27/1985SE |
| K844781 | Membrane KITS-KC1, CO2 & 02 for Instrument-LabCHL · Traditional | 02/01/1985SE |
| K844235 | Chloride StandardJIS · Traditional | 11/20/1984SE |
| K842656 | Replacement Parts Nova Electrolyte AnalJFL · Traditional | 08/12/1984SE |
| K841610 | Components for Potassium, Sodium ChloJGT · Traditional | 05/25/1984SE |
| K841609 | Components for Partial Pressure EleeCHL · Traditional | 05/25/1984SE |
| K840557 | Reagents & Standards Il 501 Na/KJGS · Traditional | 04/04/1984SE |
| K840530 | Supplies for Instrumentation Lab FlameJJO · Traditional | 03/30/1984SE |
| K840468 | Partial Press. Electrode MeasurementCHL · Traditional | 03/30/1984SE |
Questions and answers
When was Cannulas for Hema-Tek I & KK Slide Stainers cleared by the FDA?
Cannulas for Hema-Tek I & KK Slide Stainers (K850157) received a 510(k) decision of Substantially Equivalent on February 27, 1985, 43 days after the submission was received.
What is the product code of K850157?
The FDA product code is KPA – Slide Stainer, Automated, a Class I (low risk) device regulated under 21 CFR 864.3800.