The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Cobas Integra Reagent Cassettes & Ancillary Reagents.
| Device ID | K972250 |
| 510k Number | K972250 |
| Device Name: | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS |
| Classification | Catalytic Methods, Amylase |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Maria Feijoo |
| Correspondent | Maria Feijoo ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | JFJ |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CET |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CHH |
| Subsequent Product Code | DLB |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | JIF |
| Subsequent Product Code | JQB |
| Subsequent Product Code | LAS |
| Subsequent Product Code | LFM |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-16 |
| Decision Date | 1997-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336164891 | K972250 | 000 |
| 04015630914708 | K972250 | 000 |
| 04015630926985 | K972250 | 000 |
| 04015630927005 | K972250 | 000 |
| 04015630928071 | K972250 | 000 |
| 04015630924875 | K972250 | 000 |
| 04015630926886 | K972250 | 000 |
| 04015630916511 | K972250 | 000 |
| 07613336121009 | K972250 | 000 |
| 07613336121016 | K972250 | 000 |
| 07613336121603 | K972250 | 000 |
| 04015630918935 | K972250 | 000 |