Winpette
FDA 510(k) K871076 · Ulster Scientific, Inc.
510(k) numberK871076
Submission
- Device name
- Winpette
- Applicant
- Ulster Scientific, Inc.
Highland, NY, US - Received
- March 18, 1987
- Decision date
- March 23, 1987
- 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 |
|---|---|---|---|
| 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 |
| 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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|---|---|---|
| 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 |
| K870078 | Accupen(R)FMF · Traditional | 03/17/1987SE |
| K864761 | Usi Autoject Insulin SyringeFMF · Traditional | 12/16/1986SE |
Questions and answers
When was Winpette cleared by the FDA?
Winpette (K871076) received a 510(k) decision of Substantially Equivalent on March 23, 1987, 5 days after the submission was received.
What is the product code of K871076?
The FDA product code is JPH – Test, Erythrocyte Sedimentation Rate, a Class I (low risk) device regulated under 21 CFR 864.6700.