Sediplast
FDA 510(k) K840500 · Precision Technology, Inc.
510(k) numberK840500
Submission
- Device name
- Sediplast
- Applicant
- Precision Technology, Inc.
Mchenry, IL, US - Received
- February 6, 1984
- Decision date
- February 21, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPH – Test, Erythrocyte Sedimentation Rate
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.6700
- Specialty
- Hematology
Other 510(k)s with product code JPH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871076 | WinpetteJPH · Traditional | Ulster Scientific, Inc. | 03/23/1987SE |
| K860899 | Dispette IIJPH · Traditional | Ulster Scientific, Inc. | 04/14/1986SE |
| K852554 | Srt-SystemJPH · Traditional | Microwave Development, Inc. | 07/18/1985SE |
| K831195 | Westergren Dispette for EsrJPH · Traditional | Ulster Scientific, Inc. | 05/09/1983SE |
| K823761 | Erythrocyte & Stand Sediment. Rate TubeJPH · Traditional | Cordis Corp. | 01/21/1983SE |
| K823368 | Dade Esr KitJPH · Traditional | American Dade | 12/28/1982SE |
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Questions and answers
When was Sediplast cleared by the FDA?
Sediplast (K840500) received a 510(k) decision of Substantially Equivalent on February 21, 1984, 15 days after the submission was received.
What is the product code of K840500?
The FDA product code is JPH – Test, Erythrocyte Sedimentation Rate, a Class I (low risk) device regulated under 21 CFR 864.6700.