The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Clinitek 50 Urine Chemistry Analyzer.
| Device ID | K960546 |
| 510k Number | K960546 |
| Device Name: | CLINITEK 50 URINE CHEMISTRY ANALYZER |
| Classification | Automated Urinalysis System |
| Applicant | BAYER CORP. 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46514 -0070 |
| Contact | Rosanne M Savol |
| Correspondent | Rosanne M Savol BAYER CORP. 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46514 -0070 |
| Product Code | KQO |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-08 |
| Decision Date | 1996-06-12 |
| Summary: | summary |