The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Integra Reagent Cassettes & Ancillary Reagents.
Device ID | K963292 |
510k Number | K963292 |
Device Name: | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS |
Classification | Cresolphthalein Complexone, Calcium |
Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
Contact | Andrea Casper |
Correspondent | Andrea Casper ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
Product Code | CIC |
Subsequent Product Code | DBF |
Subsequent Product Code | DDQ |
Subsequent Product Code | DDR |
Subsequent Product Code | DHR |
Subsequent Product Code | JBQ |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
Subsequent Product Code | JJY |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-21 |
Decision Date | 1996-10-31 |
Summary: | summary |