The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Jt3.
Device ID | K896873 |
510k Number | K896873 |
Device Name: | COULTER JT3 |
Classification | Counter, Differential Cell |
Applicant | COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
Contact | A Richardson-jones |
Correspondent | A Richardson-jones COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-08 |
Decision Date | 1990-03-30 |