Urinoscopy Funnel
FDA 510(k) K871671 · Portable Medical Laboratories, Inc.
510(k) numberK871671
Submission
- Device name
- Urinoscopy Funnel
- Applicant
- Portable Medical Laboratories, Inc.
Solana Beach, CA, US - Received
- April 28, 1987
- Decision date
- May 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GHO – Hemocytometer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.6160
- Specialty
- Hematology
Other 510(k)s with product code GHO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K770980 | Ematology Diluent Reservoir ClosureGHO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/11/1977SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K882101 | Hemoglobin Screening DeviceKSL · Traditional | 07/01/1988SE |
| K874190 | Cell Counting Grid GraticuleIBJ · Traditional | 01/05/1988SE |
| 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 |
| K844442 | Rapid Diagnostic KitLIB · Traditional | 02/01/1985SE |
| K844473 | Hand-Held Slide ReaderLIB · Traditional | 01/04/1985SE |
Questions and answers
When was Urinoscopy Funnel cleared by the FDA?
Urinoscopy Funnel (K871671) received a 510(k) decision of Substantially Equivalent on May 20, 1987, 22 days after the submission was received.
What is the product code of K871671?
The FDA product code is GHO – Hemocytometer, a Class I (low risk) device regulated under 21 CFR 864.6160.