The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Ac.t Series Analyzer.
| Device ID | K964988 |
| 510k Number | K964988 |
| Device Name: | COULTER AC.T SERIES ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Thomas J English |
| Correspondent | Thomas J English 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 | 1996-12-13 |
| Decision Date | 1997-03-06 |
| Summary: | summary |