The following data is part of a premarket notification filed by Biocare Corp. with the FDA for Stripmax 1210 Urine Chemistry Analyzer, Urimate Reagent Strip For Urinalysis.
| Device ID | K012829 |
| 510k Number | K012829 |
| Device Name: | STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS |
| Classification | Automated Urinalysis System |
| Applicant | BIOCARE CORP. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Contact | Bruce A Macfarland |
| Correspondent | Bruce A Macfarland BIOCARE CORP. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Product Code | KQO |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIO |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-23 |
| Decision Date | 2001-11-02 |