Flask, Tissue Culture
Tissue Culture Flask is a closed, sterile laboratory vessel with a flat growth surface and a vented or sealed cap, designed to support the growth of adherent or suspension cell cultures under controlled conditions, used widely in in vitro diagnostic and biological laboratory applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KJA, regulated under 21 CFR 864.2240, within the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
Basic Information
- Product Code
- KJA
- Device Class
- FDA class 1
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972404 | VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) | Jul 22, 1997 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K933228 | KAPTON PEEL POUCH | Mar 30, 1994 | Substantially Equivalent | American Fluoroseal Corp. |
| K885121 | CELL SCRAPER | Dec 28, 1988 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K873890 | TISSUE CULTURE FLASKS | Nov 25, 1987 | Substantially Equivalent | Nunc, Inc. |
| K873889 | TISSUE CULTURE TUBES | Nov 25, 1987 | Substantially Equivalent | Nunc, Inc. |
| K871324 | DU PONT STERICELL CELL CULTURE SYSTEM | Apr 14, 1987 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K870865 | TISSUE CULTURE BAG | Mar 30, 1987 | Substantially Equivalent | American Fluoroseal Corp. |
| K864021 | TISSUE CULTURE FLASK | Oct 29, 1986 | Substantially Equivalent | Fenwal Laboratories |
| K862152 | TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD | Jun 16, 1986 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K861253 | TISSUE CULTURE FLASK PL 732 PLASTIC | Apr 11, 1986 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K853441 | FETAL BOVINE SERUM IN TRANSFER CONTAINER | Aug 26, 1985 | Substantially Equivalent | Newport Biosystems, Inc. |
| K852532 | NEWPORT MEDIA TRANSFER CONTAINER | Aug 22, 1985 | Substantially Equivalent | Newport Bio Systems |
| K823138 | CELL SCRAPER | Nov 29, 1982 | Substantially Equivalent | Corning Costar Corp. |
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.