The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Bartels Prima System Advanced Screening Cartridge.
| Device ID | K914202 |
| 510k Number | K914202 |
| Device Name: | BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | Js Mallinak |
| Correspondent | Js Mallinak BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue, WA 98009 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-19 |
| Decision Date | 1991-10-11 |