Code-A-Well Series 300 Plate
FDA 510(k) K841937 · Plastic Injectors, Inc.
510(k) numberK841937
Submission
- Device name
- Code-A-Well Series 300 Plate
- Applicant
- Plastic Injectors, Inc.
Mchenry, IL, US - Received
- May 11, 1984
- Decision date
- May 22, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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|---|---|---|---|
| K023677 | Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv)LIB · Traditional | Osmetech | 01/29/2003SE |
| K920416 | Supplementary Reagents for Enzygnost/TmbLIB · Traditional | Behring Diagnostics, Inc. | 04/08/1992SE |
| K912558 | Gull ElisawareLIB · Traditional | Gull Laboratories, Inc. | 09/16/1991SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 07/07/1987SE |
| K871559 | Cell LifterLIB · Traditional | Corning Costar Corp. | 05/15/1987SE |
| K864249 | Normal Saline SterileLIB · Traditional | Mds Laboratories, Inc. | 03/31/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 10/03/1986SE |
| K862112 | Microscope SlidesLIB · Traditional | Abco Dealers, Inc. | 06/13/1986SE |
| K854604 | Auto MashLIB · Traditional | Dynatech Corp. | 12/06/1985SE |
| K854603 | Multi Mash 2000LIB · Traditional | Dynatech Corp. | 12/06/1985SE |
More from Dynatech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K884781 | Opti-PointHET · Traditional | 01/12/1989SE |
| K863423 | Code-A-Well Series 1-1000 and Series 1-1100JTC · Traditional | 09/16/1986SE |
| K863374 | Code-A-Well Series 1-600, 1-625JTC · Traditional | 09/11/1986SE |
| K844058 | Code-A-Wall Series 1-250 Inoculum Tray · Traditional | 11/13/1984SE |
| K842848 | Code-A-Well 350 Microtitration StripsJTC · Traditional | 09/07/1984SE |
| K841632 | Code-A-Well Series 200 PlateLIB · Traditional | 05/25/1984SE |
| K841390 | Code-A-WellLIB · Traditional | 05/02/1984SE |
Questions and answers
When was Code-A-Well Series 300 Plate cleared by the FDA?
Code-A-Well Series 300 Plate (K841937) received a 510(k) decision of Substantially Equivalent on May 22, 1984, 11 days after the submission was received.
What is the product code of K841937?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.