The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Flowcare Tlg Reagent.
| Device ID | K081526 |
| 510k Number | K081526 |
| Device Name: | FLOWCARE TLG REAGENT |
| Classification | Counter, Differential Cell |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Contact | Nancy Nadler |
| Correspondent | Nancy Nadler BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2008-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590204549 | K081526 | 000 |