The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Westergren Dispette For Esr.
| Device ID | K831195 |
| 510k Number | K831195 |
| Device Name: | WESTERGREN DISPETTE FOR ESR |
| Classification | Test, Erythrocyte Sedimentation Rate |
| Applicant | ULSTER SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPH |
| CFR Regulation Number | 864.6700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-12 |
| Decision Date | 1983-05-09 |