The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Erythrocyte & Stand Sediment. Rate Tube.
Device ID | K823761 |
510k Number | K823761 |
Device Name: | ERYTHROCYTE & STAND SEDIMENT. RATE TUBE |
Classification | Test, Erythrocyte Sedimentation Rate |
Applicant | CORDIS CORP. 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 | 1982-12-14 |
Decision Date | 1983-01-21 |