The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Cobas Integra Analyzer, Reagent Cassettes.
| Device ID | K951595 |
| 510k Number | K951595 |
| Device Name: | ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Carol L Krieger |
| Correspondent | Carol L Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | CGX |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CET |
| Subsequent Product Code | CFN |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CIC |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CIX |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CKA |
| Subsequent Product Code | CZP |
| Subsequent Product Code | CZW |
| Subsequent Product Code | DBI |
| Subsequent Product Code | DCN |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-06 |
| Decision Date | 1995-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336157817 | K951595 | 000 |
| 04015630920549 | K951595 | 000 |
| 04015630918959 | K951595 | 000 |
| 04015630918928 | K951595 | 000 |
| 04015630916047 | K951595 | 000 |
| 04015630916030 | K951595 | 000 |
| 04015630916023 | K951595 | 000 |
| 04015630916016 | K951595 | 000 |
| 04015630915910 | K951595 | 000 |
| 04015630915873 | K951595 | 000 |
| 04015630915859 | K951595 | 000 |
| 04015630915798 | K951595 | 000 |
| 04015630915774 | K951595 | 000 |
| 04015630915750 | K951595 | 000 |
| 04015630915590 | K951595 | 000 |
| 04015630913855 | K951595 | 000 |
| 04015630927265 | K951595 | 000 |
| 04015630921041 | K951595 | 000 |
| 04015630921058 | K951595 | 000 |
| 07613336140680 | K951595 | 000 |
| 07613336121221 | K951595 | 000 |
| 07613336121177 | K951595 | 000 |
| 04015630997787 | K951595 | 000 |
| 04015630996667 | K951595 | 000 |
| 04015630993543 | K951595 | 000 |
| 04015630993475 | K951595 | 000 |
| 04015630993468 | K951595 | 000 |
| 04015630930777 | K951595 | 000 |
| 04015630928934 | K951595 | 000 |
| 04015630927418 | K951595 | 000 |
| 04015630926909 | K951595 | 000 |
| 04015630926831 | K951595 | 000 |
| 04015630925186 | K951595 | 000 |
| 04015630925100 | K951595 | 000 |
| 04015630921133 | K951595 | 000 |
| 04015630918973 | K951595 | 000 |