Cell Scraper
FDA 510(k) K885121 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK885121
Submission
- Device name
- Cell Scraper
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- December 12, 1988
- Decision date
- December 28, 1988
- 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 |
| 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 |
| K853441 | Fetal Bovine Serum in Transfer ContainerKJA · Traditional | Newport Biosystems, Inc. | 08/26/1985SE |
More from Newport Biosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | 06/06/2001SE |
| K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional | 03/21/2001SE |
| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Cell Scraper cleared by the FDA?
Cell Scraper (K885121) received a 510(k) decision of Substantially Equivalent on December 28, 1988, 16 days after the submission was received.
What is the product code of K885121?
The FDA product code is KJA – Flask, Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.