The following data is part of a premarket notification filed by Roche Diagnostics Gmbh with the FDA for Elecsys Calcheck Ca 125ii.
| Device ID | K981278 |
| 510k Number | K981278 |
| Device Name: | ELECSYS CALCHECK CA 125II |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ROCHE DIAGNOSTICS GMBH 4300 HACIENDA DR. Pleasanton, CA 94566 -0900 |
| Contact | Patricia M Klimley |
| Correspondent | Patricia M Klimley ROCHE DIAGNOSTICS GMBH 4300 HACIENDA DR. Pleasanton, CA 94566 -0900 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-08 |
| Decision Date | 1998-04-23 |
| Summary: | summary |