Westergren Dispette for Esr
FDA 510(k) K831195 · Ulster Scientific, Inc.
510(k) numberK831195
Submission
- Device name
- Westergren Dispette for Esr
- Applicant
- Ulster Scientific, Inc.
Mchenry, IL, US - Received
- April 12, 1983
- Decision date
- May 9, 1983
- 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 |
| K840500 | SediplastJPH · Traditional | Precision Technology, Inc. | 02/21/1984SE |
| K823761 | Erythrocyte & Stand Sediment. Rate TubeJPH · Traditional | Cordis Corp. | 01/21/1983SE |
| K823368 | Dade Esr KitJPH · Traditional | American Dade | 12/28/1982SE |
More from American Dade
| 510(k) | Device | Decision |
|---|---|---|
| K942620 | Feather-Touch Single-Stick DeviceFMK · Traditional | 06/22/1994SE |
| K920562 | UnistikFMK · Traditional | 03/27/1992SE |
| K902592 | Epc Electronic Pipetting SystemJQW · Traditional | 07/19/1990SE |
| K895890 | AutopenFMF · Traditional | 02/16/1990SE |
| K894474 | The Autolet LiteFMK · Traditional | 08/18/1989SE |
| K885340 | Air Displacement PipetteJQW · Traditional | 02/14/1989SE |
| K875354 | Unistep Capillary Blood Collection SystemLCP · Traditional | 02/17/1988SE |
| K871571 | Neurotips(Tm)GXB · Traditional | 06/18/1987SE |
| K871076 | WinpetteJPH · Traditional | 03/23/1987SE |
| K870078 | Accupen(R)FMF · Traditional | 03/17/1987SE |
Questions and answers
When was Westergren Dispette for Esr cleared by the FDA?
Westergren Dispette for Esr (K831195) received a 510(k) decision of Substantially Equivalent on May 9, 1983, 27 days after the submission was received.
What is the product code of K831195?
The FDA product code is JPH – Test, Erythrocyte Sedimentation Rate, a Class I (low risk) device regulated under 21 CFR 864.6700.