Disposable Sterile Filter System
FDA 510(k) K831450 · Corning Medical & Scientific
510(k) numberK831450
Submission
- Device name
- Disposable Sterile Filter System
- Applicant
- Corning Medical & Scientific
Walker, MI, US - Received
- May 5, 1983
- Decision date
- June 2, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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|---|---|---|---|
| K023677 | Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv)LIB · Traditional | Osmetech | 01/29/2003SE |
| K920416 | Supplementary Reagents for Enzygnost/TmbLIB · Traditional | Behring Diagnostics, Inc. | 04/08/1992SE |
| K912558 | Gull ElisawareLIB · Traditional | Gull Laboratories, Inc. | 09/16/1991SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 07/07/1987SE |
| K871559 | Cell LifterLIB · Traditional | Corning Costar Corp. | 05/15/1987SE |
| K864249 | Normal Saline SterileLIB · Traditional | Mds Laboratories, Inc. | 03/31/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 10/03/1986SE |
| K862112 | Microscope SlidesLIB · Traditional | Abco Dealers, Inc. | 06/13/1986SE |
| K854604 | Auto MashLIB · Traditional | Dynatech Corp. | 12/06/1985SE |
| K854603 | Multi Mash 2000LIB · Traditional | Dynatech Corp. | 12/06/1985SE |
More from Dynatech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K875122 | Disposable Sterile Syringe FiltersKET · Traditional | 01/12/1988SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | 07/07/1987SE |
| K872076 | Corning Disposable Roller BottlesKJB · Traditional | 06/15/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | 10/03/1986SE |
| K854024 | Corning Magic Mab HCG RadioimmunoassayJHI · Traditional | 11/26/1985SE |
| K853634 | Corning Cell Wells-Multiple Well PlatesKIZ · Traditional | 09/16/1985SE |
| K851939 | Corning Certain -IseJIX · Traditional | 06/14/1985SE |
| K851329 | Magic Monoclonal Antibody Tsh(Mab Tsh)RadioimmunoaJLW · Traditional | 06/13/1985SE |
| K850806 | Corning Blood Collection Capillary TubesGIO · Traditional | 03/25/1985SE |
| K850617 | Corning 780 Fluorometer/DensitometerJQT · Traditional | 03/12/1985SE |
Questions and answers
When was Disposable Sterile Filter System cleared by the FDA?
Disposable Sterile Filter System (K831450) received a 510(k) decision of Substantially Equivalent on June 2, 1983, 28 days after the submission was received.
What is the product code of K831450?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.