The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Ac T Diff 2 Analyzer.
| Device ID | K990352 |
| 510k Number | K990352 |
| Device Name: | COULTER AC T DIFF 2 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 | 1999-02-05 |
| Decision Date | 1999-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590264796 | K990352 | 000 |