Multiwell Culture Plate Inserts
FDA 510(k) K890542 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK890542
Submission
- Device name
- Multiwell Culture Plate Inserts
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- February 3, 1989
- Decision date
- February 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIZ – Dish, Tissue Culture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2240
- Specialty
- Hematology
Other 510(k)s with product code KIZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873891 | Tissue Culture DishesKIZ · Traditional | Nunc, Inc. | 11/25/1987SE |
| K871483 | Tissue Culture/Bacteriological Petri DishesKIZ · Traditional | Isratech Marketing Corp. | 04/29/1987SE |
| K854724 | Cekk-Adhesive Matrix-Multiple Well Plate Cam-PlateKIZ · Traditional | Lifetrac, Inc. | 12/13/1985SE |
| K853634 | Corning Cell Wells-Multiple Well PlatesKIZ · Traditional | Corning Medical & Scientific | 09/16/1985SE |
| K821687 | Removawell Tissue Culture Plate W/LidKIZ · Traditional | Dynatech Corp. | 06/24/1982SE |
| K790958 | 120 Well Histo-PlateKIZ · Traditional | Dynatech Laboratories, Inc. | 06/28/1979SE |
| K781792 | Pressurizer, Exeter CementKIZ · Traditional | Howmedica Corp. | 02/08/1979SE |
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| 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 Multiwell Culture Plate Inserts cleared by the FDA?
Multiwell Culture Plate Inserts (K890542) received a 510(k) decision of Substantially Equivalent on February 14, 1989, 11 days after the submission was received.
What is the product code of K890542?
The FDA product code is KIZ – Dish, Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.