Mcarthur Microscope Plastic Version with Acc.
FDA 510(k) K854735 · Portable Medical Laboratories, Inc.
510(k) numberK854735
Submission
- Device name
- Mcarthur Microscope Plastic Version with Acc.
- Applicant
- Portable Medical Laboratories, Inc.
Solana Beach, CA, US - Received
- November 25, 1985
- Decision date
- December 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IBJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874750 | Video Analyzer 4000IBJ · Traditional | Scientific Imaging, Inc. | 04/25/1988SE |
| K874207 | The Purple Iris(Tm) Cytopathology WorkstationIBJ · Traditional | Intl. Remote Imaging Systems | 01/05/1988SE |
| K874190 | Cell Counting Grid GraticuleIBJ · Traditional | Portable Medical Laboratories, Inc. | 01/05/1988SE |
| K864049 | Mcarthur Microscope, Standard Metal VersionIBJ · Traditional | Portable Medical Laboratories, Inc. | 10/29/1986SE |
| K823040 | Pathology Instrumentation & AccessoriesIBJ · Traditional | Iris Remote Imaging Systems | 01/14/1983SE |
| K822207 | 2XC MicroscopeIBJ · Traditional | Amarel Precision Instruments, Inc. | 08/05/1982SE |
| K821865 | A O Microscope Video SystemIBJ · Traditional | Warner-Lambert Co. | 07/14/1982SE |
| K802818 | Pullen Pocket ScopeIBJ · Traditional | P.A. Research Corp. | 04/17/1981SE |
More from P.A. Research 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 |
| K844476 | Portable Diagnostic LaboratoryLIB · Traditional | 03/13/1985SE |
| 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 Mcarthur Microscope Plastic Version with Acc. cleared by the FDA?
Mcarthur Microscope Plastic Version with Acc. (K854735) received a 510(k) decision of Substantially Equivalent on December 10, 1985, 15 days after the submission was received.
What is the product code of K854735?
The FDA product code is IBJ – Light, Microscope, a Class I (low risk) device regulated under 21 CFR 864.3600.