Cell Scraper
FDA 510(k) K823138 · Corning Costar Corp.
510(k) numberK823138
Submission
- Device name
- Cell Scraper
- Applicant
- Corning Costar Corp.
Mchenry, IL, US - Received
- October 25, 1982
- Decision date
- November 29, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KJA – Flask, Tissue Culture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2240
- Specialty
- Hematology
Other 510(k)s with product code KJA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972404 | Vacutainer Brand Safety Blood Collection Assembly(Multiple)KJA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/22/1997SE |
| K933228 | Kapton Peel PouchKJA · Traditional | American Fluoroseal Corp. | 03/30/1994SE |
| K885121 | Cell ScraperKJA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/28/1988SE |
| K873890 | Tissue Culture FlasksKJA · Traditional | Nunc, Inc. | 11/25/1987SE |
| K873889 | Tissue Culture TubesKJA · Traditional | Nunc, Inc. | 11/25/1987SE |
| K871324 | Du Pont Stericell Cell Culture SystemKJA · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/14/1987SE |
| K870865 | Tissue Culture BagKJA · Traditional | American Fluoroseal Corp. | 03/30/1987SE |
| K864021 | Tissue Culture FlaskKJA · Traditional | Fenwal Laboratories | 10/29/1986SE |
| K862152 | Tissue Culture Flask PL 732 Plastic Accessory ProdKJA · Traditional | Travenol Laboratories, S.A. | 06/16/1986SE |
| K861253 | Tissue Culture Flask PL 732 PlasticKJA · Traditional | Travenol Laboratories, S.A. | 04/11/1986SE |
More from Travenol Laboratories, S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K871559 | Cell LifterLIB · Traditional | 05/15/1987SE |
| K860703 | U - Star (Micro-Star)LHI · Traditional | 05/06/1986SE |
| K823137 | OctapettesJTC · Traditional | 12/03/1982SE |
| 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 Scraper cleared by the FDA?
Cell Scraper (K823138) received a 510(k) decision of Substantially Equivalent on November 29, 1982, 35 days after the submission was received.
What is the product code of K823138?
The FDA product code is KJA – Flask, Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.