Rapid Diagnostic Kit
FDA 510(k) K844442 · Portable Medical Laboratories, Inc.
510(k) numberK844442
Submission
- Device name
- Rapid Diagnostic Kit
- Applicant
- Portable Medical Laboratories, Inc.
Solana Beach, CA, US - Received
- November 16, 1984
- Decision date
- February 1, 1985
- 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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| 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 |
|---|---|---|
| K882101 | Hemoglobin Screening DeviceKSL · Traditional | 07/01/1988SE |
| K874190 | Cell Counting Grid GraticuleIBJ · Traditional | 01/05/1988SE |
| K871671 | Urinoscopy FunnelGHO · Traditional | 05/20/1987SE |
| K864049 | Mcarthur Microscope, Standard Metal VersionIBJ · Traditional | 10/29/1986SE |
| K854735 | Mcarthur Microscope Plastic Version with Acc.IBJ · Traditional | 12/10/1985SE |
| K844476 | Portable Diagnostic LaboratoryLIB · Traditional | 03/13/1985SE |
| K844475 | Specimen Collection & Transport SystemFMF · Traditional | 02/06/1985SE |
| K844473 | Hand-Held Slide ReaderLIB · Traditional | 01/04/1985SE |
Questions and answers
When was Rapid Diagnostic Kit cleared by the FDA?
Rapid Diagnostic Kit (K844442) received a 510(k) decision of Substantially Equivalent on February 1, 1985, 77 days after the submission was received.
What is the product code of K844442?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.