The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Stks With Reticulocyte Analysis Capability.
| Device ID | K932030 |
| 510k Number | K932030 |
| Device Name: | COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Benita Bradford |
| Correspondent | Benita Bradford 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 | 1993-04-27 |
| Decision Date | 1993-08-23 |