The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Bayer Clinitek Status Analyzer.
| Device ID | K031947 |
| 510k Number | K031947 |
| Device Name: | BAYER CLINITEK STATUS ANALYZER |
| Classification | Automated Urinalysis System |
| Applicant | BAYER HEALTHCARE, LLC 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | Mary E Gray |
| Correspondent | Mary E Gray BAYER HEALTHCARE, LLC 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | KQO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | NFZ |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-24 |
| Decision Date | 2003-12-19 |
| Summary: | summary |