The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Viscometer Ii.
Device ID | K883503 |
510k Number | K883503 |
Device Name: | COULTER VISCOMETER II |
Classification | Plasma Viscometer For Clinical Use |
Applicant | COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
Contact | Richardson-jones |
Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
Product Code | JJL |
CFR Regulation Number | 862.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-17 |
Decision Date | 1988-09-19 |