The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Integra Carbon Dioxide (co2-s), Cobas Integra Glucose Hk Liquid (glulf).
| Device ID | K980996 |
| 510k Number | K980996 |
| Device Name: | COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | James W Haynes |
| Correspondent | James W Haynes ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-17 |
| Decision Date | 1998-06-05 |
| Summary: | summary |