Portable Diagnostic Laboratory
FDA 510(k) K844476 · Portable Medical Laboratories, Inc.
510(k) numberK844476
Submission
- Device name
- Portable Diagnostic Laboratory
- Applicant
- Portable Medical Laboratories, Inc.
Solana Beach, CA, US - Received
- November 19, 1984
- Decision date
- March 13, 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
Other 510(k)s with product code LIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| 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 |
| K844475 | Specimen Collection & Transport SystemFMF · Traditional | 02/06/1985SE |
| K844442 | Rapid Diagnostic KitLIB · Traditional | 02/01/1985SE |
| K844473 | Hand-Held Slide ReaderLIB · Traditional | 01/04/1985SE |
Questions and answers
When was Portable Diagnostic Laboratory cleared by the FDA?
Portable Diagnostic Laboratory (K844476) received a 510(k) decision of Substantially Equivalent on March 13, 1985, 114 days after the submission was received.
What is the product code of K844476?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.