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 |