Cell Lifter
FDA 510(k) K871559 · Corning Costar Corp.
510(k) numberK871559
Submission
- Device name
- Cell Lifter
- Applicant
- Corning Costar Corp.
Kennebunk, ME, US - Received
- April 22, 1987
- Decision date
- May 15, 1987
- 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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|---|---|---|---|
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| K912558 | Gull ElisawareLIB · Traditional | Gull Laboratories, Inc. | 09/16/1991SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 07/07/1987SE |
| 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 |
| K854602 | Mini Mash 2000LIB · Traditional | Dynatech Corp. | 12/06/1985SE |
More from Dynatech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K860703 | U - Star (Micro-Star)LHI · Traditional | 05/06/1986SE |
| K823137 | OctapettesJTC · Traditional | 12/03/1982SE |
| K823138 | Cell ScraperKJA · Traditional | 11/29/1982SE |
| K803244 | Assay StripsJTC · Traditional | 02/02/1981SE |
| K803243 | Serocluster Flexible Vinyl U & V Pl.JTC · Traditional | 01/28/1981SE |
| K803242 | Serocluster Eia PlatesJTC · Traditional | 01/28/1981SE |
| K800240 | Serocluster U and VJTC · Traditional | 02/13/1980SE |
Questions and answers
When was Cell Lifter cleared by the FDA?
Cell Lifter (K871559) received a 510(k) decision of Substantially Equivalent on May 15, 1987, 23 days after the submission was received.
What is the product code of K871559?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.