KJA · Flask, Tissue Culture
Hematology · 21 CFR 864.2240 · Class 1
Overview
| Product Code | KJA |
|---|---|
| Device Name | Flask, Tissue Culture |
| Regulation | 21 CFR 864.2240 |
| Device Class | Class 1 |
| Review Panel | Hematology |
| GMP Exempt | Yes |
Identification
Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972404 | VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 22, 1997 | SESE |
| K933228 | KAPTON PEEL POUCH | American Fluoroseal Corp. | Mar 30, 1994 | SESE |
| K885121 | CELL SCRAPER | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 28, 1988 | SESE |
| K873890 | TISSUE CULTURE FLASKS | Nunc, Inc. | Nov 25, 1987 | SESE |
| K873889 | TISSUE CULTURE TUBES | Nunc, Inc. | Nov 25, 1987 | SESE |
| K871324 | DU PONT STERICELL CELL CULTURE SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | Apr 14, 1987 | SESE |
| K870865 | TISSUE CULTURE BAG | American Fluoroseal Corp. | Mar 30, 1987 | SESE |
| K864021 | TISSUE CULTURE FLASK | Fenwal Laboratories | Oct 29, 1986 | SESE |
| K862152 | TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD | Travenol Laboratories, S.A. | Jun 16, 1986 | SESE |
| K861253 | TISSUE CULTURE FLASK PL 732 PLASTIC | Travenol Laboratories, S.A. | Apr 11, 1986 | SESE |
| K853441 | FETAL BOVINE SERUM IN TRANSFER CONTAINER | Newport Biosystems, Inc. | Aug 26, 1985 | SESE |
| K852532 | NEWPORT MEDIA TRANSFER CONTAINER | Newport Bio Systems | Aug 22, 1985 | SESE |
| K823138 | CELL SCRAPER | Corning Costar Corp. | Nov 29, 1982 | SESE |
Top Applicants
- American Fluoroseal Corp. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Nunc, Inc. — 2 clearances
- Travenol Laboratories, S.A. — 2 clearances
- Corning Costar Corp. — 1 clearance
