Sectioning Aid Kit
FDA 510(k) K831065 · Technicon Instruments Corp.
510(k) numberK831065
Submission
- Device name
- Sectioning Aid Kit
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- April 4, 1983
- Decision date
- June 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891604 | The Cen-Slide(Tm) Centrifuge TubeKEW · Traditional | Davstar California, Inc. | 06/16/1989SE |
| K890042 | Microscope Slides PrecoatedKEW · Traditional | Stat Path | 01/13/1989SE |
| K882357 | Microscope Slides Precoated W/Histogrip & Poly-LyKEW · Traditional | Stat Path | 06/16/1988SE |
| K820100 | Frosted Glass SlidesKEW · Traditional | Stan-Pak Ent. | 03/04/1982SE |
| K813242 | Quantimetric 2 Test KitKEW · Traditional | Kallestad Laboratories, Inc. | 12/02/1981SE |
| K800232 | Abco Ultra Slide Microscope SlideKEW · Traditional | Abco Dealers, Inc. | 02/21/1980SE |
| K760278 | Slide, Lab-Tek Covered MicroKEW · Traditional | Miles Laboratories, Inc. | 08/30/1976SE |
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| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | 09/27/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
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Questions and answers
When was Sectioning Aid Kit cleared by the FDA?
Sectioning Aid Kit (K831065) received a 510(k) decision of Substantially Equivalent on June 8, 1983, 65 days after the submission was received.
What is the product code of K831065?
The FDA product code is KEW – Slides, Microscope, a Class I (low risk) device regulated under 21 CFR 864.3010.