The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia Testpoint Csf Control.
| Device ID | K022968 |
| 510k Number | K022968 |
| Device Name: | ADVIA TESTPOINT CSF CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-06 |
| Decision Date | 2002-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414472539 | K022968 | 000 |