Srt-System
FDA 510(k) K852554 · Microwave Development, Inc.
510(k) numberK852554
Submission
- Device name
- Srt-System
- Applicant
- Microwave Development, Inc.
Old Greenwich, CT, US - Received
- June 17, 1985
- Decision date
- July 18, 1985
- 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 |
| K840500 | SediplastJPH · Traditional | Precision Technology, Inc. | 02/21/1984SE |
| 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 |
Questions and answers
When was Srt-System cleared by the FDA?
Srt-System (K852554) received a 510(k) decision of Substantially Equivalent on July 18, 1985, 31 days after the submission was received.
What is the product code of K852554?
The FDA product code is JPH – Test, Erythrocyte Sedimentation Rate, a Class I (low risk) device regulated under 21 CFR 864.6700.