The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Gen-s System.
| Device ID | K962988 |
| 510k Number | K962988 |
| Device Name: | COULTER GEN-S SYSTEM |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 Miami, FL 33196 -2500 |
| Contact | Thomas J English |
| Correspondent | Thomas J English COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 Miami, FL 33196 -2500 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-01 |
| Decision Date | 1996-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590250690 | K962988 | 000 |