The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Glucose Reagent.
Device ID | K897160 |
510k Number | K897160 |
Device Name: | COULTER GLUCOSE REAGENT |
Classification | Hexokinase, Glucose |
Applicant | COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
Contact | A Richardson-jones |
Correspondent | A Richardson-jones COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
Product Code | CFR |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-28 |
Decision Date | 1990-03-09 |