The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Flow-count Coulter Fluorospheres.
Device ID | K954688 |
510k Number | K954688 |
Device Name: | FLOW-COUNT COULTER FLUOROSPHERES |
Classification | Counter, Differential Cell |
Applicant | COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
Contact | Marion S Gaide |
Correspondent | Marion S Gaide COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-11 |
Decision Date | 1996-02-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15099590542450 | K954688 | 000 |
15099590390471 | K954688 | 000 |