The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Immuno-trol Control Cells.
| Device ID | K984216 |
| 510k Number | K984216 |
| Device Name: | IMMUNO-TROL CONTROL CELLS |
| Classification | Mixture, Hematology Quality Control |
| 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 | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-24 |
| Decision Date | 1999-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590540449 | K984216 | 000 |