The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter New Meth Blue Preprep Retic/maxm W/autoloa.
| Device ID | K925344 |
| 510k Number | K925344 |
| Device Name: | COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | Richardson-jones |
| Correspondent | 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 | 1992-10-22 |
| Decision Date | 1993-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590221126 | K925344 | 000 |