Erythrocyte & Stand Sediment. Rate Tube
FDA 510(k) K823761 · Cordis Corp.
510(k) numberK823761
Submission
- Device name
- Erythrocyte & Stand Sediment. Rate Tube
- Applicant
- Cordis Corp.
Mchenry, IL, US - Received
- December 14, 1982
- Decision date
- January 21, 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 |
| K831195 | Westergren Dispette for EsrJPH · Traditional | Ulster Scientific, Inc. | 05/09/1983SE |
| K823368 | Dade Esr KitJPH · Traditional | American Dade | 12/28/1982SE |
More from American Dade
| 510(k) | Device | Decision |
|---|---|---|
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireNTE · Special | 04/06/2022SE |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsDQO · Traditional | 02/17/2022SE |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterLIT · Traditional | 04/23/2021SE |
| K202167 | Brite Tip Radianz Guiding SheathDYB · Traditional | 02/26/2021SE |
| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterLIT · Traditional | 10/09/2020SE |
| K201333 | SABER .035 PTA Dilatation CatheterLIT · Traditional | 09/11/2020SE |
| K181592 | RAIN Sheath TransradialDYB · Traditional | 08/15/2018SE |
| K180081 | RAILWAY Sheathless Access SystemDYB · Traditional | 04/18/2018SE |
| K143412 | ADROIT Guiding CatheterDQY · Special | 01/14/2015SE |
| K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation CatheterLIT · Traditional | 06/27/2014SE |
Questions and answers
When was Erythrocyte & Stand Sediment. Rate Tube cleared by the FDA?
Erythrocyte & Stand Sediment. Rate Tube (K823761) received a 510(k) decision of Substantially Equivalent on January 21, 1983, 38 days after the submission was received.
What is the product code of K823761?
The FDA product code is JPH – Test, Erythrocyte Sedimentation Rate, a Class I (low risk) device regulated under 21 CFR 864.6700.