The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Flow Set.
| Device ID | K944751 |
| 510k Number | K944751 |
| Device Name: | COULTER FLOW SET |
| Classification | Mixture, Hematology Quality Control |
| Applicant | COULTER CORP. P.O. BOX 1690 Hialeah, FL 33011 -1690 |
| Contact | Thomad J English |
| Correspondent | Thomad J English COULTER CORP. P.O. BOX 1690 Hialeah, FL 33011 -1690 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-26 |
| Decision Date | 1994-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590538163 | K944751 | 000 |